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Glossary of AbbreviationsANDA Abbreviated New Drug ApplicationAPhA American Pharmaceutical Association

API Active Pharmaceutical Ingredient

BA/BE Bioavailability/Bioequivalence

BE Bioequivalence

Bio INDs Bio Investigational New Drug ApplicationBLAs Biologic License Applications

bn BillionBPE Bulk Pharmaceutical Excipient

CAGR Compound Annual Growth Rate

CAS Chemical Abstracts Service

CBER Center for Biologics Evaluation and Research (FDA)

CDER Center for Drug Evaluation and Research (FDA)

CDRH Center for Devices and Radiological Health (FDA)

CFR Code of Federal RegulationsCFSAN Center for Food Safety and Applied Nutrition (FDA)

cGMP Current Good Manufacturing Practice

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CMIE Centre for Monitoring Indian Economy

CNS Central nervous systemCoS Certificate of Suitability

CP Citizen Petition

CPP Certificate of Pharmaceutical Product

CRAMS Contract Manufacturing and Research servicesCT Clinical Trial

CTA Clinical Trial Application

CVS Cardio Vascular System

DESI Drug Efficacy Study Implementation

DGCI&S Director General of Commercial Intelligence and StatisticsDHHS Department of Health and Human Services (U.S.)

DMF Drug Master File

DP Drug Product

DPC-PTR Act Drug Price Competition and Patent Trade Restoration Act of1984

DS Drug Substance

DSI Division of Scientific InvestigationeCTD Electronic Common Technical Document

EMEA European Agency for Evaluation of Medicinal ProductsEU European UnionFD&C ACT Federal Food, Drug, and Cosmetic Act of 1938

FDC Food, Drug, & Cosmetic

FFDCA Federal Food, Drug, and Cosmetic Act of 1938

FR Federal Register

GCLP Good Clinical Laboratory Practice

GCP Good Clinical Practice

GDEA Generic Drug Enforcement Act of 1992

GLP Good Laboratory Practice

GMP Good Manufacturing Practice

GPhA Generic Pharmaceutical Association

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HMG COA 5 Hydroxyl Methyl Glutaryl Co enzymeHS Codes Harmonized system of codesINDA Investigational New Drug ApplicationIRB Institutional Review Boardmn MillionMNC Multi National CorporationNCE New Chemical EntityNCIE National Center for Import and Export (USDA)NDA New Drug ApplicationNDC Directory National Drug Code (FDA) DirectoryNME New Molecular EntityNIPER National Institute for Pharmaceutical Education and

ResearchNSAID Non-steroidal Anti-Inflammatory DrugNTI Narrow Therapeutic IndexOGD (CDER) Office of Generic Drugs (CDER)ONL Over due notice letterOTC over the counterPAC Post Approval ChangesPHARMEXCIL Pharmaceuticals Export Promotional CouncilPHSA Public Health Service Act of 1944PTO Patent and Trademark Office (U.S. Department of

Commerce)PTR Patent Term RestorationRAPS Regulatory Affairs Professionals SocietyRLD Reference Listed DrugROW Rest of the worldRx RecipeSEC filings Securities and Exchange Commission filingsSITC Standard International Trade ClassificationTE Therapeutic EquivalenceTE Codes Therapeutic Equivalence CodeTRIPS Trade Related aspects of Intellectual Property RightsUK United KingdomUS United statesUS FDA United States Food and Drug AdministrationUSA United states of America

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USP United States PharmacopeiaUSPTO United States Patent and Trademark Office (U.S.

Department of Commerce)WHO World health organizationWL Warning LetterWW World wideYoY Year over Year

Glossary of TermsAbbreviated New Drug Application (ANDA): An Abbreviated New DrugApplication (ANDA) contains data submitted to FDA's CDER, Office ofGeneric Drugs, provides for the review and ultimate approval of a genericdrug product. Generic drug applications are called "abbreviated" becausethey are generally not required to include preclinical and clinical data toestablish safety and effectiveness ANDA demonstrate that its product isbioequivalent as the innovator drug.Active Ingredient/Drug Substance: According to 21 CFR 210.3(b)(7) and314.3, an active ingredient is any component of a drug product that isintended to furnish pharmacological activity or other direct effect in thediagnosis, cure, mitigation, treatment, or prevention of a disease, notinclude intermediates.Authorized generics: Authorised generics are brand productsmasquerading as generics compete with the true generic during the 180day marketing exclusivity period maintaining the higher price for the branddrug.ANDA Suitability Petition: ANDA suitability petitions are submitted toFDA using the format for a citizen petition approves or disapproves anANDA suitability petition within 90 days.Bioavailability: This term means the rate and extent to which the activeingredient or active moiety is absorbed from a drug product and becomesavailable at the site of action.Branded Medicines: A drug that has a trade name and is protected by apatent (can be produced and sold only by the company holding the patent).

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Blockbusters: industry term referring to drugs with very large sales,generally in excess of $1 billion.

Branded generics: Generic drugs for which a drug manufacturingcompany has attached its brand name and may have invested in itsmarketing to differentiate it from other generic brands.

Bioequivalence: Bioequivalence means that the active ingredient in ageneric medicine is absorbed into the body at the same rate and amount asin the brand-name product.BIO–IND”: The Bio-IND is required by regulations, as per 21 CFR320.31(a), to ensure that proposed products that are not new drugs(NDAor ANDA) are safe for use in human test subjects.Biologic License Application (BLA): A biologics license application underPublic Health Service (PHS) Act is a submission that contains specificinformation on the manufacturing processes, chemistry, pharmacology,clinical pharmacology and the medical affects of the biologic product.Biological Product: Biologics are isolated from a variety of natural sources.Biogenerics: A generic drug originated from Biological source has emergedfrom patent protection and can be manufactured by a company other thanRLD using either identical or different manufacturing processes.Bulk drugs: The active chemical substances in powder form, the mainingredient in pharmaceuticals having therapeutic value, used for theproduction of pharmaceutical formulations.

Citizen petition : A citizen petition is a written request for challenging anyactions taken by FDA employed to challenge the approval of ANDA or505(b)(2) applications.

Data exclusivity: Data exclusivity guarantees additional market protectionfor originator pharmaceuticals by preventing health authorities fromaccepting applications for generic medicines during the period ofexclusivity.

Discontinued Section: The identification of these drug products in theDiscontinued Section of the Orange Book should avoid the submission ofmultiple citizen petitions for the same drug product.

Discontinued Drug Product: Products listed in Drugs@FDA as"discontinued" are approved products that have never been marketed, havebeen discontinued from marketing, are for military use, are for export only,or have had their approvals withdrawn for reasons other than safety orefficacy after being discontinued from marketing.

Dosage Form: A dosage form is the physical form in which a drug isproduced and dispensed, such as a tablet, a capsule, or an injectable.

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Drug: A drug is defined as a substance intended for use in the diagnosis,cure, mitigation, treatment, or prevention of disease.

Drug Product: A finished dosage form, for example, tablet, capsule, orsolution, that contains an active ingredient.

Drug Master files (DMFs): Generic registration applications filed with theU.S.FDA in order to allow the active pharmaceutical ingredients (APIs) toappear in marketed drugs.

Desi Drugs: FDA initiated a Drug Efficacy Study Implementation (DESI) toevaluate the effectiveness of those drugs that had been previously approvedon safety grounds alone.

FDA Application Number: This number, also known as the NDA (NewDrug Application) number, is assigned by FDA staff to each application forapproval to market a new drug in the United States.Formulations: Drugs ready for consumption by patients (generic drugs)sold as a brand or generic product as tablets, capsules, injectables, orsyrups.Generic Drug: A generic drug is the same as a brand name drug in dosage,safety, strength, how it is taken, quality, performance, and intended use.Innovator drugs: Are drugs with patents on their chemical formulation oron their production process have been tested and approved by the U.S.FDA after extensive clinical trials.Marketing Status: Marketing status indicates how a drug product is soldin the United States. Drug products in Drugs@FDA are identified asPrescription,Over-the-counter,Discontinued.

Market Exclusivity: The effective period of market exclusivity gained bythe originator company is the period of data exclusivity plus the time ittakes to register and market the generic medicine.

New Drug Application (NDA): When the sponsor of a new drug believesthat enough evidence on the drug's safety and effectiveness has beenobtained to meet FDA's requirements for marketing approval, the sponsorsubmits to FDA a new drug application (NDA) data including chemistry,pharmacology, medical, biopharmaceutics, and statistics.New Molecular Entity (NME): A New Molecular Entity is an activeingredient that has never before been marketed in the United States in anyform.

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National Drug Code: National drug code (NDC) was originally establishedin connection with the reimbursement program under Medicare.Orange Book: Orange Book is commonly known as Approved DrugProducts with Therapeutic Equivalence Evaluation compiled by FDA andlists all approved drugs along with their official and proprietary names alsostores Prescription drugs (Human), OTC drugs (Human), Discontinueddrugs (Human) and patent and exclusivity listing.Over-the-Counter Drugs (OTC): FDA defines OTC drugs as safe andeffective for use by the general public without a doctor's prescription.Pharmaceuticals: Are used to prevent, diagnose, treat, or cure diseases inhumans and animals.Plain vanilla generics: Commodity generics that are “off-patent” in theregulated markets. They offer little or no innovative value over theinnovator’s product.Proprietary drugs: Drugs that have a trade or brand name and areprotected by a patent.Pharmaceutical Equivalents: FDA considers drug products to bepharmaceutical equivalents if they contain the same active ingredient(s),same dosage form and route of administration, identical in strength orconcentration.Prescription Drug Product: A prescription drug product requires adoctor's authorization to purchase.Patent: Patents are registrable provides a patentee the right to preventanyone making, using, selling, or importing the invention for 20 years.Patents can be expired before drug approval, issued after drug approval,and anywhere in between. Exclusivity is granted upon approval of a drugproduct if the statutory requirements are met. Some drugs have bothpatent and exclusivity protection while others has just one or none.

Patent Delist: In the event of the filing of a patent infringement actionbased on an ANDA or 505(b)(2) application, the applicant may assert acounterclaim to correct or delete the patent list if the patent listing if thepatent does not claim the approved drug or an approved method of use.Patent Certifications: There are four types of patent certification issuedby the FDA. They are Paragraph –I (No patents for the reference listed drugwere listed in the Orange book), Paragraph –II (Patents were listed in theOrange book but they all have expired on the date of submission is sent tothe FDA), Paragraph -III (the patent has not expired but will expire on aparticular date) and Paragraph –IV) are submitted when the applicant ischallenging the patent(s).Patent settlements: To ensure prompt generic market entry and to punishcompanies that might enter into an anticompetitive agreement someagencies can request changes to settlements, and take the appropriateaction.

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RLD (Reference Listed Drug): A Reference Listed Drug (RLD) is anapproved drug product to which new generic versions are compared toshow that they are bioequivalent.Tentative Approval: If a generic drug product is ready for approval beforethe expiration of patents FDA issues a tentative approval letter to theapplicant but does not allow the applicant to market the generic drugproduct.Therapeutic Biological Product: A therapeutic biological product is aprotein derived from living material (such as cells or tissues) used to treator cure disease.Therapeutic Equivalence (TE): Drug products classified as therapeuticallyequivalent can be substituted with the full expectation that the substitutedproduct will produce the same clinical effect and safety profile as theprescribed product.

Therapeutic Equivalence (TE) Codes: FDA assigns therapeuticequivalence codes to pharmaceutically equivalent drug products like "A"rated if not "B" rated. Over the counter drugs are not assigned TE codes.