INSTITUTIONAL EQUITY RESEARCH Pharmaceuticalsbackoffice.phillipcapital.in/Backoffice/Researchfiles/PC_-_Pharma... · INSTITUTIONAL EQUITY RESEARCH ... manufactured by Indian generic

INSTITUTIONAL EQUITY RESEARCH

Page | 1 | PHILLIPCAPITAL INDIA RESEARCH

Pharmaceuticals US policy concerns pricing; a relief from “price negotiations” INDIA | PHARMACEUTICALS | Sector Update

29 June 2017

USFDA, with an intention to contain rising drug prices, has unveiled a two‐pronged approach to increase competition in the market for prescription drugs and facilitate entry of lower‐cost alternatives: (1) it has made public 267 drugs with no generic competition (even after the expiry of patent as well as exclusivity) in order to encourage new generic filling, and (2) it has outlined a new policy – prioritized review process of generic drug applications and faster drug approvals. The details of its approach and our observations are as follows: No Indian peer except Jubilant Life affected due to the 267 drugs made public USFDA’s move – to make public 267 drugs that are off patent and off exclusivity with no generic competition – is to improve transparency and encourage the development and submission of ANDAs in markets with no competition. Our study of this list suggests that most listed drugs are injectables (129 injectables, 71 oral dosages, others). In the list, 15 are manufactured by Indian generic companies – 7 from Sun Pharma (covering three radio pharma drugs of Pharmalucense and one from Ranbaxy), five from Jubilant Life Sciences, and one each from Dr Reddy’s, Emcure, and Alkem. However, except for Jubilant Life Sciences, none of the Indian peers make influential drug (>1% of their respective US generic sales). Jubilant’s five products in the list belong to its radio‐pharma business, which is its highest earnings contributor (~10% of sales and >40% earnings). Any generic competition in this product class could hurt its future profitability. Prioritised approval/review process of ANDAs with limited competition Considering that limited or no competition has been the key reason for spiraling drug prices, the USFDA has prioritized its review process of generic drug applications (ANDAs). It expects to expedite the approval of ANDAs until there are three approved generics for a given drug product. Additionally, its priority list covers drugs under shortages, President’s Emergency Plan for AIDS Relief (PEFAR) program, certain government purchasing programs, and public health emergencies. Such a policy – one that will enhance competition at a time of channel consolidation – could lead to generic price erosion and hurt the growth outlook for generic players in the near future. However, the rising focus of Indian peers towards complex generics and specialty pharma products would mitigate the concern of enhanced competition. Our study of the top‐10 generic products of Indian players (excluding exclusive opportunities) in the US (contributing over 50% of their US generic sales) suggests that none fall under the priority list with less than three generic competitors. The key exception is Sun Pharma’s gDoxil (Pegylated Liposomal Doxorubicin HCl) injection – that has two generic competitors and generates about 4% of its total US sales. Our take: A great relief that US regulators are not resorting to “price negotiations” While the USFDA’s new policy initiatives come at a time of enhanced channel consolidation, and raise concerns about increased price competition, it is a great relief for the generic industry that the regulator is not adopting the approach of compulsory price negotiations that it had mentioned earlier. In the current regulatory/pricing scenario, we believe players such as Aurobindo Pharma, with its well‐diversified drug portfolio and no price leadership, are well placed.

Companies Aurobindo Pharma Reco BUY CMP, Rs 671 Target Price, Rs 780 Biocon Ltd Reco NEUTRAL CMP, Rs 328 Target Price, Rs 370 Cadila Healthcare Reco NEUTRAL CMP, Rs 529 Target Price, Rs 470 Cipla Ltd Reco NEUTRAL CMP, Rs 537 Target Price, Rs 460 Divis Labs Reco BUY CMP, Rs 640 Target Price, Rs 690 Dr Reddy’s Labs Reco NEUTRAL CMP, Rs 2654 Target Price, Rs 3000 Glenmark Pharma Reco BUY CMP, Rs 629 Target Price, Rs 910 IPCA Reco NEUTRAL CMP, Rs 479 Target Price, Rs 480 Lupin Ltd Reco BUY CMP, Rs 1065 Target Price, Rs 1550 Sun Pharma Reco NEUTRAL CMP, Rs 540 Target Price, Rs 620 Surya Patra (+ 9122 6246 4121) [email protected] Mehul Sheth (+ 9122 6246 4123) [email protected]

mailto:[email protected]



PHARMACEUTICALS SECTOR UDPATE

Drug products relating to Indian peers included in USFDA’s priority list Companies Ingredient Brand name Type Alkem SILVER SULFADIAZINE THERMAZENE Topical Cream Dr Reddy's Lab CLOCORTOLONE PIVALATE CLODERM Topical Cream Emcure CARMUSTINE BICNU Inj Jubilant RUBIDIUM CHLORIDE RB‐82 RUBY‐FILL Inj Jubilant SODIUM IODIDE I‐131 SODIUM IODIDE I 131 Caps Jubilant TECHNETIUM TC‐99M ALBUMIN AGGREGATED KIT TECHNETIUM TC Inj Jubilant TECHNETIUM TC‐99M MEDRONATE DRAXIMAGE MDP‐25 Inj Jubilant TECHNETIUM TC‐99M PENTETATE KIT DTPA Inj Sun Pharma ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE SYNALGOS‐DC Caps Sun Pharma DESVENLAFAXINE FUMARATE DESVENLAFAXINE Tabs ER Ranbaxy (Sun Pharma) HALCINONIDE HALOG Topical Ointment Sun Pharma SULCONAZOLE NITRATE EXELDERM Topical Solu Pharmalucence (Sun Pharma) TECHNETIUM TC‐99M DISOFENIN KIT HEPATOLITE Inj Pharmalucence (Sun Pharma) TECHNETIUM TC‐99M MEDRONATE KIT CIS‐MDP Inj Pharmalucence (Sun Pharma) TECHNETIUM TC‐99M PYROPHOSPHATE KIT CIS‐PYRO Inj Valuation summary

CMP ___EPS (Rs)___ EPS Growth (%) ___PE (X)___ EV/EBITDA (X) ___ROE (%)___ CAGR Reco. TP %(Rs) FY18e FY19e FY18e FY19e FY18e FY19e FY18e FY19e FY18e FY19e EPS (%) (RS) Upside

Aurobindo Pharma 671 42.8 48.8 8.8 14.0 15.7 13.7 10.4 8.9 22.2 20.7 11.4 BUY 780 16Biocon 328 8.8 11.7 ‐13.4 32.5 37.1 28.0 7.5 6.1 11.6 14.5 7.1 NEUTRAL 370 13Cadila Healthcare 529 20.6 21.4 41.5 4.1 25.7 24.7 19.0 17.6 25.4 21.6 21.4 NEUTRAL 470 ‐11Cipla 537 19.4 25.5 55.2 31.1 27.6 21.1 16.3 12.9 11.3 12.9 42.6 NEUTRAL 460 ‐14Divis 640 36.1 40.6 ‐12.9 12.3 17.7 15.8 12.4 10.8 16.9 16.8 (1.1) BUY 690 8Dr Reddy's Labs. 2,654 117.6 149.4 57.5 27.1 22.6 17.8 14.1 11.4 13.6 15.0 41.5 NEUTRAL 3000 13Glenmark Pharma 629 50.2 56.6 7.9 12.7 12.5 11.1 8.6 7.5 21.9 20.0 10.3 BUY 910 45IPCA 479 24.9 37.0 60.4 48.2 19.2 13.0 10.6 7.6 11.2 14.2 54.2 NEUTRAL 480 0Lupin 1,065 66.2 77.2 3.0 16.5 16.1 13.8 10.4 8.7 19.0 18.5 9.5 BUY 1550 46Sun Pharma 545 25.9 29.6 ‐10.7 14.4 21.0 18.4 12.0 10.1 14.9 14.9 1.0 NEUTRAL 620 14

Source: Company, PhillipCapital India Research Estimates



Part I – List of drugs for which FDA could immediately accept an ANDA without prior discussion Ingredient Approved NDA Brand Name Type Innovator ACETYLCHOLINE CHLORIDE N020213 MIOCHOL‐E Opthal solu Valeant ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE N019806 SEMPREX‐D Caps Endo Pharma ALBENDAZOLE N020666 ALBENZA Tabs Impax Pharma ALPHA‐TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'‐PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K

N021163; N021559 INFUVITE ADULT Inj Sandoz

AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

N018582 PROCALAMINE Inj B BRAUN

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

N020678 CLINIMIX E Inj Baxter

AMINO ACIDS; DEXTROSE N020734 CLINIMIX Inj Baxter AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE

N016822 FREAMINE III Inj B BRAUN

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE

N017789 AMINOSYN Inj ICU MEDICAL INC

AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

N016822 FREAMINE III Inj B BRAUN

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

N019437 AMINOSYN II Inj ICU MEDICAL INC

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

N017673; N017789 AMINOSYN 7%/8.5%

Inj ICU MEDICAL INC

AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE N050824 OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN

Caps GastroEntero‐Logic

APOMORPHINE HYDROCHLORIDE N021264 APOKYN Inj US WorldMeds ARGININE HYDROCHLORIDE N016931 R‐GENE 10 Inj Pfizer ARTEMETHER; LUMEFANTRINE N022268 COARTEM Inj Novartis ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K

N021265; N021646 INFUVITE PEDIATRIC

Inj Sandoz

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'‐PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E

N018920 INFUVITE PEDIATRIC

Inj Sandoz

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'‐PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E

N008809 M.V.I.‐12 Inj Hospira

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'‐PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K

N021625; N021643 M.V.I. ADULT Inj Hospira

ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE N011483 SYNALGOS‐DC Caps Sun Pharma ATROPINE SULFATE N021146; N206289 ATROPINE SULFATE Opthal solu Akorn ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE N017744 MOTOFEN Tabs SEBELA IRELAND LTD ATROPINE SULFATE; EDROPHONIUM CHLORIDE N019678 ENLON‐PLUS Inj Mylan AURANOFIN N018689 RIDAURA Caps SEBELA IRELAND LTD BARIUM SULFATE N208036; N208143;

N208844 VARIBAR Paste oral BRACCO

DIAGNOSTICS INC BENTOQUATAM N020532 IVY BLOCK Topical Lotion Standard

Homeopathic BENZYLPENICILLOYL POLYLYSINE N050114 PRE‐PEN Inj ALLERQUEST Pharma BETAINE HYDROCHLORIDE N020576 CYSTADANE Oral Solu Rare Disease

Therapeutics BOSENTAN N021290 TRACLEER Tabs Actelion Pharma BRINZOLAMIDE N020816 AZOPT Opthal Susp Novartis BUTENAFINE HYDROCHLORIDE N020524; N021307 LOTRIMIN ULTRA Topical Cream Bayer Healthcare CALCIUM CHLORIDE N021117 CALCIUM

CHLORIDE 10% Inj Hospira



Ingredient Approved NDA Brand Name Type Innovator CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE

N018469; N020079 ENDOSOL EXTRA Solu Irrigation Akorn

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

N021703 PRISMASOL BK Inj Baxter

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

N017512; N018883; N020163; N020171; N020183

DIANEAL LOW CALCIUM

SOLU INTRAPERITONEAL

Baxter

CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

N020577 ELLIOTTS B SOLUTION

Inj LUKARE MEDICAL LLC

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE N018254; N020000 DEXTROSE 5% Inj B BRAUN CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

N016679; N017608; N019367; N019634; N019685

POTASSIUM CHLORIDE

Inj ICU MEDICAL INC

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

N018895 TPN ELECTROLYTES Inj Hospira

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE N016693; N017635; N018156; N018251; N018495;N020002

RINGER'S Inj B BRAUN

CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE

N016682; N017641; N018494; N018681; N018921;N019416; N019632

LACTATED RINGER'S

Inj B BRAUN

CAPREOMYCIN SULFATE N050095 CAPASTAT SULFATE Inj Akorn CARBOPROST TROMETHAMINE N017989 HEMABATE Inj Pfizer CARMUSTINE N017422 BICNU Inj Emcure CHLORAMBUCIL N010669 LEUKERAN Tabs Apean Global CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE N012750 LIBRAX Caps Valeant CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE

N022113 ADVIL ALLERGY AND CONGESTION RELIEF

Tabs Pfizer

CHROMIC CHLORIDE N018961 CHROMIC CHLORIDE

Inj Hospira

CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE N019481 RENACIDIN Solu Irrigation United‐Guardian CITRIC ACID; UREA C‐13 N021314 IDKIT:HP Tabs EXALENZ BIOSCIENCECLOCORTOLONE PIVALATE N017765 CLODERM Topical Cream Dr Reddy's Lab CUPRIC CHLORIDE N018960 CUPRIC CHLORIDE Inj Hospira DALFOPRISTIN; QUINUPRISTIN N050748 SYNERCID Inj KING PHARMS DALTEPARIN SODIUM N020287 FRAGMIN Inj Pfizer DESFLURANE N020118 SUPRANE LIQUID;INHAL

ATION Baxter

DESVENLAFAXINE N204150; N204683 KHEDEZLA Tabs Osmotica Pharma DESVENLAFAXINE FUMARATE N205583 DESVENLAFAXINE Tabs ER Sun Pharma DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE

N017385 PLASMA‐LYTE 56 Inj Baxter

DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE

N017610 NORMOSOL‐M AND DEXTROSE 5%

Inj ICU MEDICAL INC

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE

N019873 ISOLYTE P IN DEXTROSE

Inj B BRAUN

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE

N017484 DEXTROSE 5% AND ELECTROLYTE

Inj Baxter

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS

N019513 IONOSOL MB AND DEXTROSE

Inj ICU MEDICAL INC

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

N019844 ISOLYTE H IN DEXTROSE 5%

Inj B BRAUN

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

N017609 NORMOSOL‐R AND DEXTROSE 5%

Inj ICU MEDICAL INC

DEXTROSE; POTASSIUM CHLORIDE N017634; N018371; N019699

POTASSIUM CHLORIDE 0.3%

Inj B BRAUN

Ingredient Approved NDA Brand Name Type Innovator



DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE

N019870 ISOLYTE M IN DEXTROSE 5%

Inj B BRAUN

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE N018008; N018037; N018362; N018365; N018629;N018876; N019308; N019630; N019691

POTASSIUM CHLORIDE 5MEQ

Inj ICU MEDICAL INC

DEXTROSE; SODIUM CHLORIDE N016678; N016683; N016687; N016689; N016696;N016697; N017585; N017606; N017607; N017799;N019631

DEXTROSE 5% AND SODIUM CHLORIDE 0.9%

Inj B BRAUN

DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE N011324 SINOGRAFIN Solu Irrigation BRACCO DIAGNOSTICS INC

DIMERCAPROL N005939 BAL Inj Akorn DINOPROSTONE N017810; N019617;

N020411 CERVIDIL Insert ER

Vaginal Ferring Pharma

DOLASETRON MESYLATE N020623; N020624 ANZEMET Inj Pfizer ECHOTHIOPHATE IODIDE N011963 PHOSPHOLINE

IODIDE Opthal solu Pfizer

EDETATE CALCIUM DISODIUM N008922 CALCIUM DISODIUM VERSENATE

Inj Medicis

EFLORNITHINE HYDROCHLORIDE N021145 VANIQA Topical Cream SkinMedica EMEDASTINE DIFUMARATE N020706 EMADINE Opthal solu Novartis ENFUVIRTIDE N021481 FUZEON Inj Roche ESOMEPRAZOLE STRONTIUM N202342 ESOMEPRAZOLE

STRONTIUM Caps DR R2 Pharma

ESTRAMUSTINE PHOSPHATE SODIUM N018045 EMCYT Caps Pfizer ESTROGENS, CONJUGATED N004782; N010402 PREMARIN Inj Pfizer ETHANOLAMINE OLEATE N019357 ETHAMOLIN Inj QOL Medical ETHIONAMIDE N013026 TRECATOR Tabs Pfizer ETOPOSIDE PHOSPHATE N020457 ETOPOPHOS

PRESERVATIVE FREE

Inj BMS

EZOGABINE N022345 POTIGA Tabs Glaxo FLUORESCEIN SODIUM N021980; N022186 AK‐FLUOR

25%/10% Inj Akorn

FOSFOMYCIN TROMETHAMINE N050717 MONUROL Opthal Susp Zambon Group GLUTAMINE N021667 NUTRESTORE Oral Solu Emmaus Life GLYCINE N016784; N017865;

N018315 GLYCINE 1.5% Solu Irrigation ICU MEDICAL INC

GUAIFENESIN; HYDROCODONE BITARTRATE N022424; N205474 OBREDON Oral Solu Sovereign Pharma GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

N022279 HYCOFENIX Oral Solu Mission Pharma

HALCINONIDE N017556; N017824 HALOG Topical Ointment

Sun Pharma

HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE N021956 DUTOPROL Tabs ER Concordia International

HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE N019261 PAREMYD Opthal solu Akorn IDOXURIDINE N014169 DENDRID Opthal solu Alcon ILOPROST N021779 VENTAVIS Inhaler Solu ACTELION PHARMS LODOXAMIDE TROMETHAMINE N020191 ALOMIDE Opthal solu Novartis LOMUSTINE N017588 GLEOSTINE Caps Corden Pharma LOTEPREDNOL ETABONATE N020583 LOTEMAX Opthal solu Valeant LOTEPREDNOL ETABONATE; TOBRAMYCIN N050804 ZYLET Opthal solu Valeant MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

N019696 ISOLYTE S PH 7.4 Inj B BRAUN



Ingredient Approved NDA Brand Name Type Innovator MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

N017378; N017586; N017637; N019024; N019711

ISOLYTE S Inj B BRAUN

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM PHOSPHATE

N018336; N018508 TIS‐U‐SO Solu Irrigation Baxter

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE N204553 COLPREP KIT Oral Powder Gator Pharm MANGANESE CHLORIDE N018962 MANGANESE

CHLORIDE Inj Hospira

MANNITOL; SORBITOL N018316 SORBITOL‐MANNITOL

Solu Irrigation ICU MEDICAL INC

MESTRANOL; NORETHINDRONE N016659 NORINYL 1+50 Tabs Actavis METHACHOLINE CHLORIDE N019193 PROVOCHOLINE Inhaler Solu Methapharm METHOHEXITAL SODIUM N011559 BREVITAL SODIUM Inj Par Pharma MIGLUSTAT N021348 ZAVESCA Caps Acetelion Pharma MITOTANE N016885 LYSODREN Tabs BMS NABILONE N018677 CESAMET Caps Mylan NELFINAVIR MESYLATE N020779; N021503 VIRACEPT Tabs Pfizer OLSALAZINE SODIUM N019715 DIPENTUM Caps Mylan OXYMETHOLONE N016848 ANADROL‐50 Tabs Mylan PENICILLAMINE N019853; N019854 DEPEN Tabs Mylan PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE N050138 BICILLIN C‐R Inj KING PHARMS PENTAZOCINE LACTATE N016194 TALWIN Inj Hospira PENTETATE CALCIUM TRISODIUM N021749 PENTETATE

CALCIUM TRISODIUM

Inhaler Solu Hameln pharma

PENTETATE ZINC TRISODIUM N021751 PENTETATE ZINC TRISODIUM

Inhaler Solu Hameln pharma

PENTOSAN POLYSULFATE SODIUM N020193 ELMIRON Caps Janseen POVIDONE‐IODINE N018634; N019522 POVIDONE IODINE Topical Solu Henry Ford AllegiancePRALIDOXIME CHLORIDE N014134; N018986 PRALIDOXIME

CHLORIDE Inj Meridian Medical

PRAZIQUANTEL N018714 BILTRICIDE Tabs Bayer Healthcare PROCARBAZINE HYDROCHLORIDE N016785 MATULANE Caps Leadiant Biosciences PURIFIED WATER N022305 PUR‐WASH Opthal solu Niagara Pharma PYRIMETHAMINE N008578 DARAPRIM Tabs Turing Pharma SAQUINAVIR MESYLATE N020628; N021785 INVIRASE Tabs Roche SODIUM ACETATE ANHYDROUS N018893 SODIUM ACETATE Inj Hospira SODIUM LACTATE N018947 SODIUM LACTATE Inj Hospira SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

N018892 SODIUM PHOSPHATES

Inj Hospira

SORBITOL N016741; N017863 SORBITOL 3% Solu Irrigation Baxter STERILE WATER FOR IRRIGATION N016734; N017428;

N017513; N017866; N018313

STERILE WATER LIQUID; Irrigation

ICU MEDICAL INC

STREPTOZOCIN N050577 ZANOSAR Inj Teva TENIPOSIDE N020119 VUMON Inj WG Critical Care TETRACAINE HYDROCHLORIDE N208135 TETRACAINE

HYDROCHLORIDE Opthal solu Novartis

THIOGUANINE N012429 THIOGUANINE Tabs Aspean TOREMIFENE CITRATE N020497 FARESTON Tabs Kyowa Hakko Kirin TRIAMCINOLONE HEXACETONIDE N016466 ARISTOSPAN Inj Sandoz TRIAMTERENE N013174 DYRENIUM Caps Concordia

International TRIENTINE HYDROCHLORIDE N019194 SYPRINE Caps Valeant TRIMETHOPRIM HYDROCHLORIDE N074973 PRIMSOL Oral Solu Aytu BioScience TRIPTORELIN PAMOATE N020715; N021288;

N022437 TRELSTAR Inj Allergan

TROMETHAMINE N013025 THAM Inj Hospira TRYPAN BLUE N021670; N022278 MEMBRANEBLUE Opthal solu DORC VERTEPORFIN N021119 VISUDYNE Inj Valeant

Source: US FDA, PhillipCapital India Research



Part II – List of drug products involving potential legal, regulatory, or scientific issues – which should be addressed with the Agency before submission of an ANDA Ingredient Approved NDA Brand Name Type Innovator ACETOHYDROXAMIC ACID N018749 LITHOSTAT Tabs Mission Pharma ALBUMIN IODINATED I‐125 SERUM N017836 JEANATOPE Inj ISO‐TEX

DIAGNOSTICS ALBUMIN IODINATED I‐131 SERUM N017837 MEGATOPE Inj ISO‐TEX

DIAGNOSTICS ALCOHOL; CHLORHEXIDINE GLUCONATE N021074 AVAGARD Topical Solu 3M Health Care ALITRETINOIN N020886 PANRETIN Topical Gel Eisai ALTRETAMINE N019926 HEXALEN Caps Eisai AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL

N200656 PERIKABIVEN Emulsion IV FRESENIUS KABI

ATROPINE; PRALIDOXIME CHLORIDE N021983 DUODOTE Inj Meridian Medical AVOBENZONE; ECAMSULE; OCTOCRYLENE N021501; N021502 ANTHELIOS SX Topical Cream LOREAL USA AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE N021471; N022009 ANTHELIOS 40 Topical Cream LOREAL USA AVOBENZONE; OCTINOXATE; OXYBENZONE N020045 SHADE UVAGUARD Topical Lotion Bayer Healthcare BECLOMETHASONE DIPROPIONATE MONOHYDRATE N019389 BECONASE AQ Nasal Spray Glaxo BERACTANT N020032 SURVANTA Suspension

intra Abbive

CALFACTANT N020521 INFASURF PRESERVATIVE

Suspension intra

Ony inc

CARMUSTINE N020637 GLIADEL IMPLANT;INTRACRANIAL

Arbor Pharma

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE N018397 CHLOR‐TRIMETON Tabs ER Bayer Healthcare CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE N020805 CIPRO HC COLY‐MYCIN

S Novartis

CLOFAZIMINE N019500 LAMPRENE Caps Novartis COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE

N050356 COLY‐MYCIN S COLY‐MYCIN S

Endo Pharma

COPPER N018680 PARAGARD T INTRAUTERINE DEVICE;INTRAUTERINE

Teva

CORTICORELIN OVINE TRIFLUTATE* N020162 ACTHREL Inj Ferring Pharma DESIRUDIN RECOMBINANT* N021271 IPRIVASK Inj Valeant DOCOSANOL N020941 ABREVA Topical Cream Glaxo DOXYCYCLINE CALCIUM N050480 VIBRAMYCIN Susp Oral Pfizer ESTRADIOL HEMIHYDRATE N021371 ESTRASORB Emulsion

Topical Exeltis USA

ESTRADIOL; LEVONORGESTREL N021258 CLIMARA PRO Transdermal Film

Bayer Healthcare

ESTROGENS, CONJUGATED N020216 PREMARIN CREAM;TOPICAL, VAGINAL

Novartis

ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE N020527 PREMPRO Tabs Novartis ETHOTOIN N010841 PEGANONE Tabs Recordati Rare FERRIC HEXACYANOFERRATE(II) N021626 RADIOGARDASE Caps Heyl Chemisch FLUOROMETHOLONE ACETATE N019079 FLAREX Opthal Susp Novartis GADOBENATE DIMEGLUMINE N021357; N021358 MULTIHANCE

MULTIPACK Inj BRACCO

DIAGNOSTICS INC GADODIAMIDE N020123; N022066 OMNISCAN Inj GE Healthcare GADOPENTETATE DIMEGLUMINE N019596; N021037 MAGNEVIST Inj Bayer Healthcare GADOTERIDOL N020131; N021489 PROHANCE

MULTIPACK Inj BRACCO

DIAGNOSTICS INC GADOVERSETAMIDE N020937; N020975;

N020976 OPTIMARK Inj Liebel‐Flarsheim

GALLIUM CITRATE GA‐67 N017478; N018058 GALLIUM CITRATE Inj MALLINKRODT GENTAMICIN SULFATE; PREDNISOLONE ACETATE N050586; N050612 PRED‐G Opthal

oinment Allergan

GLUCAGON HYDROCHLORIDE N201849 GLUCAGON Intravenus FRESENIUS KABI



Powder GLUCAGON HYDROCHLORIDE RECOMBINANT

N020918 GLUCAGEN Inj Novo Nordisk

Ingredient Approved NDA Brand Name Type Innovator GLUCAGON RECOMBINANT N020928 GLUCAGON Inj Eli Lilly GONADOTROPIN, CHORIONIC* N017016; N017067;

N017692 PREGNYL Inj Merck

GUANIDINE HYDROCHLORIDE N001546 GUANIDINE HYDROCHLORIDE

Tabs Merck

HEXACHLOROPHENE N017433 PRE‐OP II Topical Sponge

Pfizer

HYALURONIDASE N021640; N021665 AMPHADASE Inj Amphastar Pharma HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE N050218 CORTISPORIN Topical Cream Pfizer HYDROCORTISONE PROBUTATE N020453 PANDEL Topical Cream Sandoz HYDROXYPROPYL CELLULOSE N018771 LACRISER Opthal insert Valeant IMIGLUCERASE* N020367 CEREZYME Inj Sanofi INDIUM IN‐111 CHLORIDE N019841; N019862 INDICLOR Inj GE Healthcare INDIUM IN‐111 OXYQUINOLINE N019044 INDIUM IN 111 Inj GE Healthcare INDIUM IN‐111 PENTETATE DISODIUM N017707 MPI INDIUM DTPA Inj GE Healthcare IOBENGUANE SULFATE I‐123 N022290 ADREVIEW Inj GE Healthcare IODINE POVACRYLEX; ISOPROPYL ALCOHOL N021586 DURAPREP Topical

Sponge 3M Health Care

IODIPAMIDE MEGLUMINE N009321 CHOLOGRAFIN MEGLUMINE

Inj BRACCO DIAGNOSTICS INC

IODIXANOL N020351; N020808 VISIPAQUE 320/270 Inj GE Healthcare IOFLUPANE I‐123 N022454 DATSCAN Inj GE Healthcare IOHEXOL N018956; N020608;

N205383 ORALTAG Oral Solu Interpharma Praha

IOPROMIDE N020220; N021425 ULTRAVIST Inj Bayer Healthcare IOTHALAMATE MEGLUMINE N013295; N016983;

N017057 CYSTO‐CONRAY II Inj Liebel‐Flarsheim

IOTHALAMATE SODIUM I‐125 N017279 GLOFIL‐125 Inj ISO‐TEX DIAGNOSTICS

IOVERSOL N019710; N020923 OPTIRAY 350 Inj Liebel‐Flarsheim IRON DEXTRAN N017441; N017807;

N040024 DEXFERRUM Inj Luitpold Pharma

IRON SUCROSE N021135 VENOFER Inj Luitpold Pharma ISOCARBOXAZID N011961 MARPLAN Tabs Validus Pharma ISONIAZID; PYRAZINAMIDE; RIFAMPIN N050705 RIFATER Tabs Sanofi LEUPROLIDE ACETATE; NORETHINDRONE ACETATE N203696 LUPANETA PACK Inj Abbive LIOTRIX (T4;T3) N016807 THYROLAR Tabs Allergan LOTEPREDNOL ETABONATE N020803; N200738;

N202872 LOTEMAX Opthal Gel Valeant

MEPENZOLATE BROMIDE N010679 CANTIL Tabs Sanofi METHSUXIMIDE N010596 CELONTIN Caps Pfizer METYRAPONE N012911 METOPIRONE Caps HRA Pharma METYROSINE N017871 DEMSER Caps Valeant NAFARELIN ACETATE N019886 SYNAREL Nasal Spray Pfizer NATAMYCIN N050514 NATACYN Opthal Susp Novartis NESIRITIDE RECOMBINANT N020920 NATRECOR Inj Janssen NONOXYNOL‐9 N018683 TODAY Vaginal

Sponge Mayer Laboratories

PEGADEMASE BOVINE* N019818 ADAGEN Inj Sigma‐Tau PEGAPTANIB SODIUM N021756 MACUGEN Inj Valeant PEGVISOMANT* N021106 SOMAVERT Inj Pfizer PORACTANT ALFA N020744 CUROSURF Inj Chiesi USA PORFIMER SODIUM N020451 PHOTOFRIN Inj Concordia

International POVIDONE‐IODINE N019240; N019476 E‐Z SCRUB 241 Topical

Sponge Becton Dickinson

PSEUDOEPHEDRINE SULFATE N018191 AFRINOL Tabs ER Merck



RIFAPENTINE N021024 PRIFTIN Tabs Sanofi RUBIDIUM CHLORIDE RB‐82 N019414; N202153 RUBY‐FILL Inj Jubilant SALMETEROL XINAFOATE N020692 SEREVENT Inhaler

Powder Glaxo

Ingredient Approved NDA Brand Name Type Innovator SAMARIUM SM‐153 LEXIDRONAM PENTASODIUM N020570 QUADRAMET Inj Lantheus Medical SECRETIN SYNTHETIC HUMAN N021256 CHIRHOSTIM Inj ChiRhoClin SERTACONAZOLE NITRATE N021385 ERTACZO Topical Cream Valeant SILVER SULFADIAZINE N017381; N018578;

N018810 THERMAZENE Topical Cream Alkem

SODIUM FLUORIDE; TRICLOSAN N020231 COLGATE TOTAL Dental Paste COLGATE PALMOLIVE

SODIUM IODIDE I‐131 N016515; N016517; N021305

SODIUM IODIDE I 131

Caps Jubilant

SOYBEAN OIL N017643; N018449; N019531; N019942; N020248

INTRALIPID 20% Inj FRESENIUS KABI

SUCCIMER N019998 CHEMET Caps Recordati Rare SULCONAZOLE NITRATE N018737; N018738 EXELDERM Topical Solu Sun Pharma TALC N020587; N021388;

N205555 STERITALC POWDER;INT

RAPLEURAL Novatech SA

TECHNETIUM TC‐99M ALBUMIN AGGREGATED KIT N017776; N017881 TECHNETIUM TC Inj Jubilant TECHNETIUM TC‐99M BICISATE KIT N020256 NEUROLITE Inj Lantheus Medical TECHNETIUM TC‐99M DISOFENIN KIT N018467 HEPATOLITE Inj Sun Pharma TECHNETIUM TC‐99M EXAMETAZIME KIT N019829 CERETEC Inj GE Healthcare TECHNETIUM TC‐99M MEDRONATE N018035 DRAXIMAGE MDP‐

25 Inj Jubilant

TECHNETIUM TC‐99M MEDRONATE KIT N018107; N018124 CIS‐MDP Inj Sun Pharma TECHNETIUM TC‐99M MERTIATIDE KIT N019882 TECHNESCAN

MAG3 Inj MALLINKRODT

TECHNETIUM TC‐99M OXIDRONATE KIT N018321 TECHNESCAN Inj MALLINKRODT TECHNETIUM TC‐99M PENTETATE KIT N017714; N018511 DTPA Inj Jubilant TECHNETIUM TC‐99M PYROPHOSPHATE KIT N017538; N019039 CIS‐PYRO Inj Sun Pharma TECHNETIUM TC‐99M RED BLOOD CELL KIT N019981 ULTRATAG Inj MALLINKRODT TECHNETIUM TC‐99M SODIUM PERTECHNETATE GENERATOR N017243; N017693;

N017771 TECHNELITE Inj Lantheus Medical

TECHNETIUM TC‐99M TETROFOSMIN KIT N020372 MYOVIEW Inj GE Healthcare TERBINAFINE N021958 LAMISIL AT Topical Gel Novartis THYROTROPIN ALFA* N020898 THYROGEN Inj Sanofi TIOPRONIN N019569 THIOLA Tabs Mission Pharma TRIMETHADIONE N005856 TRIDIONE Tabs Abbive UREA, C‐14 N020617 PYTEST KIT Caps Sanofi VALRUBICIN N020892 VALSTAR

PRESERVATIVE FREE Inj Endo Pharma

XENON XE‐133 N017284; N018327 XENON XE 133 Inhaler Gas MALLINKRODT ZANAMIVIR N021036 RELENZA Inhaler

Powder Glaxo

ZINC ACETATE N020458 GALZIN Caps Teva ZINC CHLORIDE N018959 ZINC CHLORIDE Inj Hospira ZIPRASIDONE MESYLATE N020919 GEODON Inj Pfizer

Source: US FDA, PhillipCapital India Research




Rating Methodology We rate stock on absolute return basis. Our target price for the stocks has an investment horizon of one year. Rating Criteria Definition

BUY >= +15% Target price is equal to or more than 15% of current market price

NEUTRAL ‐15% > to < +15% Target price is less than +15% but more than ‐15%

SELL <= ‐15% Target price is less than or equal to ‐15%.

Management Vineet Bhatnagar (Managing Director) (91 22) 2483 1919 Kinshuk Bharti Tiwari (Head – Institutional Equity) (91 22) 6246 4101 Jignesh Shah (Head – Equity Derivatives) (91 22) 6667 9735 Research Automobiles IT Services Pharma & Specialty Chem Dhawal Doshi (9122) 6246 4128 Vibhor Singhal (9122) 6246 4109 Surya Patra (9122) 6246 4121 Nitesh Sharma, CFA (9122) 6246 4126 Shyamal Dhruve (9122) 6246 4110 Mehul Sheth (9122) 6246 4123 Banking, NBFCs Infrastructure Strategy Manish Agarwalla (9122) 6246 4125 Vibhor Singhal (9122) 6246 4109 Naveen Kulkarni, CFA, FRM (9122) 6246 4122 Pradeep Agrawal (9122) 6246 4113 Paresh Jain (9122) 6246 4114 Logistics, Transportation & Midcap Telecom Consumer & Retail Vikram Suryavanshi (9122) 6246 4111 Naveen Kulkarni, CFA, FRM (9122) 6246 4122 Naveen Kulkarni, CFA, FRM (9122) 6246 4122 Media Manoj Behera (9122) 6246 4118 Jubil Jain (9122) 6246 4117 Manoj Behera (9122) 6246 4118 Technicals Preeyam Tolia (9122) 6246 4129 Metals Subodh Gupta, CMT (9122) 6246 4136 Cement Dhawal Doshi (9122) 6246 4128 Production Manager Vaibhav Agarwal (9122) 6246 4124 Ganesh Deorukhkar (9122) 6667 9966 Economics Mid-Caps & Database Manager Editor Anjali Verma (9122) 6246 4115 Deepak Agarwal (9122) 6246 4112 Roshan Sony 98199 72726 Shruti Bajpai (9122) 6246 4135 Oil & Gas Sr. Manager – Equities Support Engineering, Capital Goods Sabri Hazarika (9122) 6667 9756 Rosie Ferns (9122) 6667 9971 Jonas Bhutta (9122) 6246 4119 Vikram Rawat (9122) 6246 4120 Sales & Distribution Corporate Communications Ashvin Patil (9122) 6246 4105 Sales Trader Zarine Damania (9122) 6667 9976 Shubhangi Agrawal (9122) 6246 4103 Dilesh Doshi (9122) 6667 9747 Kishor Binwal (9122) 6246 4106 Suniil Pandit (9122) 6667 9745 Bhavin Shah (9122) 6246 4102 Ashka Mehta Gulati (9122) 6246 4108 Execution Archan Vyas (9122) 6246 4107 Mayur Shah (9122) 6667 9945

Contact Information (Regional Member Companies)

SINGAPORE: Phillip Securities Pte Ltd 250 North Bridge Road, #06‐00 RafflesCityTower,

Singapore 179101 Tel : (65) 6533 6001 Fax: (65) 6535 3834

www.phillip.com.sg

MALAYSIA: Phillip Capital Management Sdn Bhd B‐3‐6 Block B Level 3, Megan Avenue II,

No. 12, Jalan Yap Kwan Seng, 50450 Kuala Lumpur Tel (60) 3 2162 8841 Fax (60) 3 2166 5099

www.poems.com.my

HONG KONG: Phillip Securities (HK) Ltd 11/F United Centre 95 Queensway Hong Kong Tel (852) 2277 6600 Fax: (852) 2868 5307

www.phillip.com.hk

JAPAN: Phillip Securities Japan, Ltd 4‐2 Nihonbashi Kabutocho, Chuo‐ku

Tokyo 103‐0026 Tel: (81) 3 3666 2101 Fax: (81) 3 3664 0141

www.phillip.co.jp

INDONESIA: PT Phillip Securities Indonesia ANZTower Level 23B, Jl Jend Sudirman Kav 33A,

Jakarta 10220, Indonesia Tel (62) 21 5790 0800 Fax: (62) 21 5790 0809

www.phillip.co.id

CHINA: Phillip Financial Advisory (Shanghai) Co. Ltd. No 550 Yan An East Road, OceanTower Unit 2318

Shanghai 200 001 Tel (86) 21 5169 9200 Fax: (86) 21 6351 2940

www.phillip.com.cn

THAILAND: Phillip Securities (Thailand) Public Co. Ltd. 15th Floor, VorawatBuilding, 849 Silom Road,

Silom, Bangrak, Bangkok 10500 Thailand Tel (66) 2 2268 0999 Fax: (66) 2 2268 0921

www.phillip.co.th

FRANCE: King & Shaxson Capital Ltd. 3rd Floor, 35 Rue de la Bienfaisance

75008 Paris France Tel (33) 1 4563 3100 Fax : (33) 1 4563 6017

www.kingandshaxson.com

UNITED KINGDOM: King & Shaxson Ltd. 6th Floor, Candlewick House, 120 Cannon Street

London, EC4N 6AS Tel (44) 20 7929 5300 Fax: (44) 20 7283 6835

www.kingandshaxson.com

UNITED STATES: Phillip Futures Inc. 141 W Jackson Blvd Ste 3050

The Chicago Board of TradeBuilding Chicago, IL 60604 USA

Tel (1) 312 356 9000 Fax: (1) 312 356 9005

AUSTRALIA: PhillipCapital Australia Level 10, 330 Collins Street

Melbourne, VIC 3000, Australia Tel: (61) 3 8633 9800 Fax: (61) 3 8633 9899

www.phillipcapital.com.au

SRI LANKA: Asha Phillip Securities Limited Level 4, Millennium House, 46/58 Navam Mawatha,

Colombo 2, Sri Lanka Tel: (94) 11 2429 100 Fax: (94) 11 2429 199

www.ashaphillip.net/home.htm

INDIA PhillipCapital (India) Private Limited

No. 1, 18th Floor, Urmi Estate, 95 Ganpatrao Kadam Marg, Lower Parel West, Mumbai 400013 Tel: (9122) 2300 2999 Fax: (9122) 6667 9955 www.phillipcapital.in

http://www.phillip.com.sg/

http://www.poems.com.my/

http://www.phillip.com.hk/

http://www.phillip.co.jp/

http://www.phillip.co.id/

http://www.phillip.com.cn/

http://www.phillip.co.th/

http://www.kingandshaxson.com/

http://www.kingandshaxson.com/

http://www.phillipcapital.com.au/

http://www.ashaphillip.net/home.htm

http://www.phillipcapital.in/


Disclosures and Disclaimers PhillipCapital (India) Pvt. Ltd. has three independent equity research groups: Institutional Equities, Institutional Equity Derivatives, and Private Client Group. This report has been prepared by Institutional Equities Group. The views and opinions expressed in this document may, may not match, or may be contrary at times with the views, estimates, rating, and target price of the other equity research groups of PhillipCapital (India) Pvt. Ltd.

This report is issued by PhillipCapital (India) Pvt. Ltd., which is regulated by the SEBI. PhillipCapital (India) Pvt. Ltd. is a subsidiary of Phillip (Mauritius) Pvt. Ltd. References to "PCIPL" in this report shall mean PhillipCapital (India) Pvt. Ltd unless otherwise stated. This report is prepared and distributed by PCIPL for information purposes only, and neither the information contained herein, nor any opinion expressed should be construed or deemed to be construed as solicitation or as offering advice for the purposes of the purchase or sale of any security, investment, or derivatives. The information and opinions contained in the report were considered by PCIPL to be valid when published. The report also contains information provided to PCIPL by third parties. The source of such information will usually be disclosed in the report. Whilst PCIPL has taken all reasonable steps to ensure that this information is correct, PCIPL does not offer any warranty as to the accuracy or completeness of such information. Any person placing reliance on the report to undertake trading does so entirely at his or her own risk and PCIPL does not accept any liability as a result. Securities and Derivatives markets may be subject to rapid and unexpected price movements and past performance is not necessarily an indication of future performance.

This report does not regard the specific investment objectives, financial situation, and the particular needs of any specific person who may receive this report. Investors must undertake independent analysis with their own legal, tax, and financial advisors and reach their own conclusions regarding the appropriateness of investing in any securities or investment strategies discussed or recommended in this report and should understand that statements regarding future prospects may not be realised. Under no circumstances can it be used or considered as an offer to sell or as a solicitation of any offer to buy or sell the securities mentioned within it. The information contained in the research reports may have been taken from trade and statistical services and other sources, which PCIL believe is reliable. PhillipCapital (India) Pvt. Ltd. or any of its group/associate/affiliate companies do not guarantee that such information is accurate or complete and it should not be relied upon as such. Any opinions expressed reflect judgments at this date and are subject to change without notice.

Important: These disclosures and disclaimers must be read in conjunction with the research report of which it forms part. Receipt and use of the research report is subject to all aspects of these disclosures and disclaimers. Additional information about the issuers and securities discussed in this research report is available on request.

Certifications: The research analyst(s) who prepared this research report hereby certifies that the views expressed in this research report accurately reflect the research analyst’s personal views about all of the subject issuers and/or securities, that the analyst(s) have no known conflict of interest and no part of the research analyst’s compensation was, is, or will be, directly or indirectly, related to the specific views or recommendations contained in this research report.

Additional Disclosures of Interest: Unless specifically mentioned in Point No. 9 below: 1. The Research Analyst(s), PCIL, or its associates or relatives of the Research Analyst does not have any financial interest in the company(ies) covered in

this report. 2. The Research Analyst, PCIL or its associates or relatives of the Research Analyst affiliates collectively do not hold more than 1% of the securities of the

company (ies)covered in this report as of the end of the month immediately preceding the distribution of the research report. 3. The Research Analyst, his/her associate, his/her relative, and PCIL, do not have any other material conflict of interest at the time of publication of this

research report. 4. The Research Analyst, PCIL, and its associates have not received compensation for investment banking or merchant banking or brokerage services or for

any other products or services from the company(ies) covered in this report, in the past twelve months. 5. The Research Analyst, PCIL or its associates have not managed or co‐managed in the previous twelve months, a private or public offering of securities for

the company (ies) covered in this report. 6. PCIL or its associates have not received compensation or other benefits from the company(ies) covered in this report or from any third party, in

connection with the research report. 7. The Research Analyst has not served as an Officer, Director, or employee of the company (ies) covered in the Research report. 8. The Research Analyst and PCIL has not been engaged in market making activity for the company(ies) covered in the Research report. 9. Details of PCIL, Research Analyst and its associates pertaining to the companies covered in the Research report: Sr. no. Particulars Yes/No

1 Whether compensation has been received from the company(ies) covered in the Research report in the past 12 months for investment banking transaction by PCIL

No

2 Whether Research Analyst, PCIL or its associates or relatives of the Research Analyst affiliates collectively hold more than 1% of the company(ies) covered in the Research report

No

3 Whether compensation has been received by PCIL or its associates from the company(ies) covered in the Research report No4 PCIL or its affiliates have managed or co‐managed in the previous twelve months a private or public offering of securities for the

company(ies) covered in the Research report No

5 Research Analyst, his associate, PCIL or its associates have received compensation for investment banking or merchant banking or brokerage services or for any other products or services from the company(ies) covered in the Research report, in the last twelve months

No

Independence: PhillipCapital (India) Pvt. Ltd. has not had an investment banking relationship with, and has not received any compensation for investment banking services from, the subject issuers in the past twelve (12) months, and PhillipCapital (India) Pvt. Ltd does not anticipate receiving or intend to seek compensation for investment banking services from the subject issuers in the next three (3) months. PhillipCapital (India) Pvt. Ltd is not a market maker in the securities mentioned in this research report, although it, or its affiliates/employees, may have positions in, purchase or sell, or be materially interested in any of the securities covered in the report.

Suitability and Risks: This research report is for informational purposes only and is not tailored to the specific investment objectives, financial situation or particular requirements of any individual recipient hereof. Certain securities may give rise to substantial risks and may not be suitable for certain investors. Each investor must make its own determination as to the appropriateness of any securities referred to in this research report based upon the legal, tax and accounting considerations applicable to such investor and its own investment objectives or strategy, its financial situation and its investing experience. The value of any security may be positively or adversely affected by changes in foreign exchange or interest rates, as well as by other financial, economic, or political factors. Past performance is not necessarily indicative of future performance or results.




Sources, Completeness and Accuracy: The material herein is based upon information obtained from sources that PCIPL and the research analyst believe to be reliable, but neither PCIPL nor the research analyst represents or guarantees that the information contained herein is accurate or complete and it should not be relied upon as such. Opinions expressed herein are current opinions as of the date appearing on this material, and are subject to change without notice. Furthermore, PCIPL is under no obligation to update or keep the information current. Without limiting any of the foregoing, in no event shall PCIL, any of its affiliates/employees or any third party involved in, or related to computing or compiling the information have any liability for any damages of any kind including but not limited to any direct or consequential loss or damage, however arising, from the use of this document.

Copyright: The copyright in this research report belongs exclusively to PCIPL. All rights are reserved. Any unauthorised use or disclosure is prohibited. No reprinting or reproduction, in whole or in part, is permitted without the PCIPL’s prior consent, except that a recipient may reprint it for internal circulation only and only if it is reprinted in its entirety.

Caution: Risk of loss in trading/investment can be substantial and even more than the amount / margin given by you. Investment in securities market are subject to market risks, you are requested to read all the related documents carefully before investing. You should carefully consider whether trading/investment is appropriate for you in light of your experience, objectives, financial resources and other relevant circumstances. PhillipCapital and any of its employees, directors, associates, group entities, or affiliates shall not be liable for losses, if any, incurred by you. You are further cautioned that trading/investments in financial markets are subject to market risks and are advised to seek independent third party trading/investment advice outside PhillipCapital/group/associates/affiliates/directors/employees before and during your trading/investment. There is no guarantee/assurance as to returns or profits or capital protection or appreciation. PhillipCapital and any of its employees, directors, associates, and/or employees, directors, associates of PhillipCapital’s group entities or affiliates is not inducing you for trading/investing in the financial market(s). Trading/Investment decision is your sole responsibility. You must also read the Risk Disclosure Document and Do’s and Don’ts before investing.

Kindly note that past performance is not necessarily a guide to future performance.

For Detailed Disclaimer: Please visit our website www.phillipcapital.in

For U.S. persons only: This research report is a product of PhillipCapital (India) Pvt Ltd., which is the employer of the research analyst(s) who has prepared the research report. The research analyst(s) preparing the research report is/are resident outside the United States (U.S.) and are not associated persons of any U.S.‐regulated broker‐dealer and therefore the analyst(s) is/are not subject to supervision by a U.S. broker‐dealer, and is/are not required to satisfy the regulatory licensing requirements of FINRA or required to otherwise comply with U.S. rules or regulations regarding, among other things, communications with a subject company, public appearances, and trading securities held by a research analyst account.

This report is intended for distribution by PhillipCapital (India) Pvt Ltd. only to "Major Institutional Investors" as defined by Rule 15a‐6(b)(4) of the U.S. Securities and Exchange Act, 1934 (the Exchange Act) and interpretations thereof by the U.S. Securities and Exchange Commission (SEC) in reliance on Rule 15a 6(a)(2). If the recipient of this report is not a Major Institutional Investor as specified above, then it should not act upon this report and return the same to the sender. Further, this report may not be copied, duplicated, and/or transmitted onward to any U.S. person, which is not a Major Institutional Investor. In reliance on the exemption from registration provided by Rule 15a‐6 of the Exchange Act and interpretations thereof by the SEC in order to conduct certain business with Major Institutional Investors, PhillipCapital (India) Pvt Ltd. has entered into an agreement with a U.S. registered broker‐dealer, Decker & Co, LLC. Transactions in securities discussed in this research report should be effected through Decker & Co, LLC or another U.S. registered broker dealer. If Distribution is to Australian Investors This report is produced by PhillipCapital (India) Pvt Ltd and is being distributed in Australia by Phillip Capital Limited (Australian Financial Services Licence No. 246827). This report contains general securities advice and does not take into account your personal objectives, situation and needs. Please read the Disclosures and Disclaimers set out above. By receiving or reading this report, you agree to be bound by the terms and limitations set out above. Any failure to comply with these terms and limitations may constitute a violation of law. This report has been provided to you for personal use only and shall not be reproduced, distributed or published by you in whole or in part, for any purpose. If you have received this report by mistake, please delete or destroy it, and notify the sender immediately. PhillipCapital (India) Pvt. Ltd. Registered office: No. 1, 18th Floor, Urmi Estate, 95 Ganpatrao Kadam Marg, Lower Parel West, Mumbai 400013

http://www.phillipcapital.in/

Documents

INSTITUTIONAL EQUITY RESEARCH Pharmaceuticalsbackoffice.phillipcapital.in/Backoffice/Researchfiles/PC_-_Pharma... · INSTITUTIONAL EQUITY RESEARCH ... manufactured by Indian generic