Pharmaceutical Medicines By Nootan Pharmaceuticals, Himachal Pradesh

CORPORATE OFFICE

502, Citi Centre, Erandwane, Karve Road, Dist-Pune, Maharashtra.

Phone No. (020) 25458481, (020) 25459619

MANAUFACTURING SITE

Vill-Tipra, Barotiwala-Kalka Road, Barotiwala, Dist- Solan

Himachal Pradesh- 174103, INDIA

Phone No. (01792) 253022, 033

Email Id- [email protected]

Website- www.nootanpharma.net, www.nootanpharma.com

mailto:[email protected]

http://www.nootanpharma.net/

http://www.nootanpharma.com/

3/5/2013 2Nootan Pharmaceuticals

ISO 9001:2008 certified

WHO GMP certified company

3/5/2013 Nootan Pharmaceuticals 3



Engaged in manufacturing of

Cephalosporin formulations


Tablet

Injectable

Dry

Syrup

Capsule

Group Strategy:

Around the World

-With the Customer

Group Culture:

• Determination

• Integrity

• Professional, Reliable, T

rustworthy;

• Pride

• Spirit

• Team Work

Our mission


Our Mission:

Strong Focus on delivering

the Best, Cost Effective

Services and Formulations

to cater to the needs of

our clients.

PharmaceuticalFormulations




Manufacturing area

Utility Area

Laboratory Area

Stores & Dispensing

Gardening Area



Plant is well equipped with all modern

technology, with competent technical

personnel carrying out all activities, in

order to deliver highest quality products


Injectables

Product list of Injectables


Sr.

No.Generic name Strength (Each Vial)

1. Cefotaxim Sodium 125mg , 250mg, 500mg, 1gm

2. Ceftriaxone Sodium250mg, 500mg, 1gm, 2gm,

3gm

3. Cefuroxime Axetil 250mg, 750mg, 1.5gm

4. Ceftazidime Pentahydrate 250mg, 500mg, 1gm

5. Cefpirome Sodium 500mg, 1gm

6. Cefoperazone Sodium 500mg

7. Cefoperazone Sodium 1gm, 2gm

8. Cefazoline Sodium 125mg, 250mg, 500mg, 1gm

9. Cefipime Hydrochloride 1gm

10. Meropenem Trihydrate 250mg, 500mg, 1gm

11. Ceftizoxime 250mg, 500mg, 1gm

12. Cefoperazone Sodium and Sulbactum Sodium500mg, 1gm, 1.5gm, 3gm,

4.5gm

13. Ceftriaxone sodium and Sulbactum sodium 1gm, 1.5gm, 3gm, 4.5gm

14. Cefepime and Tazobactum sodium 500mg, 1gm

15. Ceftriaxone Sodium and Tazobactum Sodium 1gm, 1.5gm

List of machinery in Injectables


Sr

no.

EQUIPMENT ID Equipment name Make/ manufacturer

1 NPB/P/I-01 Auto. Inj. Filling & stop. Mc Vacuumech engineers

2 NPB/P/I-02 Automatic ink jet printer Domino a -series

3 NPB/P/I-03 Automatic sticker labeling m/c Vacuumech engineers

4 NPB/P/I-04 Bung wash m/c YASH

5 NPB/P/I-05 DHS Sapphire

6 NPB/P/I-06 Rotary vial washing machine Vacuumech engineers

7 NPB/P/I-07 Turn table (1) Nm

8 NPB/P/I-08 Autoclave ESteem engineering

9 NPB/P/I-09 Vial sealing machine Vacuumech

10 NPB/P/I-10 Optical inspection m/c Bonfiglio group

11 NPB/P/I-11 Electronic balance Contech instrument ltd

Continued..


…..Continued

Sr No. Equipment ID Equipment Name Make/ Manufacturer

12 NPB/P/I-12 Electronic Balance SAMSON

13 NPB/P/I-13 Conveyor Belt Amba

14 NPB/P/I-14 Turn Table Amba

15 NPB/P/I-15 L A FGMP Technical Solution pvt

ltd

16 NPB/P/I-16 L A FGMP Technical Solution pvt

ltd.

17 NPB/P/I-17 Blender YASH

18 NPB/P/I-18 Blender YASH

19 NPB/P/I-19 Pass box (ss) YASH

20 NPB/P/I-20 Pass box (ss) GMP Technical Solution pvt

ltd

21 NPB/P/I-21 Pass box (ss) GMP Technical Solution pvt

ltd

22 NPB/P/I-22 Shrink Wrap M/C Ultra pack

23 NPB/P/I-23 Striping M/C Ultra pack



Tablet and Capsule


Product list of Tablets

Sr.

No.Generic name Strength (Each tablet)

1. Cefpodoxime Proxetil tablets 50mg, 100mg, 200mg

2. Cefixime Trihydrate tablets 50mg, 100mg, 200mg

3. Cefuroxime Axetil tablets 125mg, 250mg, 500mg

4. Cefditoren Pivoxil Tablets 100mg, 200mg, 400mg

5. Cefdinir Tablets 100mg, 125mg, 200mg

6. Ceftamet Pivoxil Tablets 250mg, 500mg

7. Cephalexin Monohydrate tablets 125mg, 250mg, 500mg, 750mg

8. Cefadroxyl Monohydrate tablets 125mg, 250mg, 500mg

9. Cefaclor tablets 125mg, 250mg, 375mg, 750mg

10. Cefpodoxime Proxetil and Pot. Clavulanate Tablets 325mg

11. Cefixime Trihydrate and Pot. Clavulanate Tablets 325mg

12. Cefuroxime Axetil and Pot. Clavulanate tablets 325mg, 625mg

13. Cefadroxyl and Potassium Clavulanate tablets 325mg, 625mg


Product list of Capsule

Sr.

No.Generic name Strength (Each Capsule)

1. Cephalexin Monohydrate 250mg , 500mg

2. Cephadroxyl monohydrate 250mg, 500mg

3. Cefdinir 300mg


List of machinery in Tablet & Capsules


1 NPB/P/T-01 Blister Packing Machine VM SERVICES

2 NPB/P/T-02 Coating M/C Sehgal Industrial Works

3 NPB/P/T-03 Compression Machine 27 Stn-I ACCURA

4 NPB/P/T-04 Compression Machine 27 Stn II ACCURA

5 NPB/P/T-05 Fluid Bed Dryer (FBD)YASH

6 NPB/P/T-06 Batch Coding/Printing Mach. (Carton)YASH

7.A NPB/P/T-07 A Octagonal BlenderBrilliant Pharma

Machines

7.B NPB/P/T-07B Octagonal Blender YASH

8 NPB/P/T-08 Rapid Mixer Granulator (RMG) YASH

9 NPB/P/T-09 Tablet dedusting M/C FP Machinery

Continued..


…..Continued

Sr

No.Equipment ID Equipment Name Make/ Manufacturer




13 NPB/P/T-13 DEB M/C FP Machinery

14 NPB/P/T-14 DEB M/C FP Machinery

15 NPB/P/T-15 Water Cooler For Blister Unitech

16 NPB/P/T-16 Colloidal MillYASH

17 NPB/P/T-17 Conveyor Belt Machine For Blister YASH

18 NPB/P/T-18 MultimillYASH

19 NPB/P/T-19 MultimillYASH

Continued..



20 NPB/P/T-20 Vibro-Sifter NM

21 NPB/P/T-21 Inspection M/C NM

22 NPB/P/T-22 Conveyor Belt ALU-ALU(Packing Area) NM

23 NPB/P/T-23 Alu-Alu packing M/C Accurate

24 NPB/P/T-24 Strip Packing M/C Kulbindra

25 NPB/P/T-25 Electronic Balance Samson



28 NPB/P/T-28 Hydrolic Pellet Divya

29 NPB/P/T-29 Tray Dryer Brillient

…..Continued



Dry Syrup


Product list of Dry Syrup

Sr.

No.Generic name

Strength

(Each 5ml )

1. Cefixime Trihydrtae susp. 50mg, 100mg

2. Cephalexin susp. 100mg, 125mg, 250mg

3. Cefadroxyl Monohydrate susp 125mg, 250mg

4. Cefaclor 50mg, 125mg, 187mg

5. Ceftibuten 400mg

6. Cefpodoxime Proxetil susp. 50mg, 100mg

7. Cefdinir Susp. 125mg

8. Ceftemate Pivoxil susp. 250mg

9. Cefprozil 125mg

10. Cefixime and Lactobacillus sporogens 50mg & 20 MIU

11. Cephalexin and Bromohexin Hydrochloride susp. 127mg (125mg & 2mg)

12. Cephalexin and Carbocystiene 400mg (250mg & 150mg)

13. Cefadroxyl and Potassium Clavulanate susp. 156.25mg (125mg & 31.25mg)

14. Cefpodoxime Proxetil and Potassium Clavulanate susp. 86.25mg (50mg & 31.25mg)

15. Cefixime and Potassium Clavulanate susp. 86.25mg (50mg & 31.25mg)


QualityControl

Quality Standard Planning

Production

Inspection &

Control

Improvement &Training

Production &Inspection


Planning Production

Quality Policy

We are committed to earn highest level

of satisfaction and trust of its customers

by delivering high quality products on

time.

We shall continually improve our

products, process, systems and train the

employees for continual improvement &

achieve zero error stage.



Quality Control

Chemical &

InstrumentationMicrobiology


List of equipments in Quality Control

Continued…

Sr. No. Name of Instruments Make

1 HPLC Autosampler Shimadzu

2 FTIR Spectrophotometer Shimadzu

3 Dissolution Apparatus Labindia

4 Balances Labtronics

5 Disintegration Test Apparatus (Double unit) Today Tech Scientific Solution

6 Electronic Balance Afcoset

7 Friability Apparatus Labtronics

8 Leak Test Apparatus Today-Tech Scientific Solution

9 PH Meter Labtronics

10 Sonicator Today-Tech Scientific Solution

11 Centrifugal Apparatus Today-Tech Scientific Solution

12 Hardness Tester Monsento


Sr. No. Name of Instruments Make

13 Karl Fischer Titrator Labtronics

14 IR Moisture Balance-1 RIODE

15 Bulk Density Tester Today Tech Scientific Solution

16 Digital Potentiometer Labtronics

17 Abbe Refractometer Today Tech Scientific Solution

18 Automatic Melting Point Labtronics

19 Stability Chamber Osworld

20 Incubators Osworld

21 Autoclave Osworld

22 Vortex Shaker Today Tech Scientific Solution

…continued

Quality Control

Well equipped facility for chemical &

microbiological testing.


Microbiology Lab Well equipped microbiology lab.

Environmental monitoring, bacterial

endotoxin test, sterility test, microbial

limit test & bioburden of WFI & finished

product is carried out as per Schedule L.




Quality Assurance


QA is the heart and soul of quality control

QA = QC + GMP

Regular evaluations of the quality ofproducts is conducted with the objectiveof verifying the consistency of theprocess and ensuring its continuousimprovement.


Regulatory Activities related to FDA, getting

product permission, COPP, etc.

Self Inspection

Documentation

Qualification - DQ, IQ, OQ & PQ

Validation – Prospective, Concurrent,

Retrospective & Revalidation

Calibration

Recall, Market Complaint & Out of Specification

Quality Assurance Activities


Continue building presence in oversees markets.

Continue evolution as an innovative developer of pharmaceuticals products

To become a leading player formulations supply to global companies


Vision

Investment Highlight Fully integrated company with strong presence across entire value chain

from formulations to export and across key therapy areas and both the

evolving and developing markets

Strong manufacturing facilities

Strong marketing and distribution network


Personnel looking for export activity

Ms. Smita Phatak South East Asia, Asia Pacific,

Middle East, Africa, Latin

America

Mr. Dinesh Kothari India & Other unrepresented

countries

Regulatory Affairs Compliance with overseas company regulations and laws pertaining to

the manufacture, marketing and development of pharmaceuticals

products.

A bridge between the company, its products and regulatory authorities

Regulatory’s team interacts with worldwide, federal, state, and localregulatory agencies to assure:

licensing,

registration,

development,

manufacturing,

marketing and

labeling

…….of pharmaceutical and medical products are conducted incompliance with all applicable rules


Personnel looking for Regulatory Activity

Ms. Sheetal (B.Pharm)

Ms. Shailee (M.Pharm)

Ms. Sonal (B.Pharm)

Ms. Sweety (B.Pharm)

Regulatory team working in the Head Office, Pune

so as to deliver country- specific Dossiers.


Nootan Pharmaceuticals is looking forward

for a successful business relationship with

overseas clients, giving assurance of

delivering highest quality products and

good service.


……………………Thank

you


Business

Pharmaceutical Medicines By Nootan Pharmaceuticals, Himachal Pradesh