SITE MASTER FILE - Group Pharmaceutical Limited

1 site MASTER FILE DOCUMENT NO. SUPERSEDES DOC. NO. EFFECTIVE FROM PAGE NO. SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 1 OF 51 INDEX SL. No. TITLE PAGE NO. 1. INDEX 1 2. APPROVAL SHEET 2 GENERAL INFORMATION 3 TO 15 PERSONNEL 15 TO 18 PREMISES AND EQUIPMENT 18 TO 34 DOCUMENTATION 35 TO 36 PRODUCTION 37 TO 44 QUALITY CONTROL 45 TO 46 CONTRACT MANUFACTURE AND ANALYSIS 47 DISTRIBUTION, COMPLAINTS AND PRODUCT RECALLS 47 TO 49 SELF INSPECTION 50 CHANGE HISTORY 51 SL. NO. ANNEXURE PARTICULARS 01 ANNEXURE I Photocopy of Manufacturing Licence 02 ANNEXURE II List of Equipments & Instruments 03 ANNEXURE III Layouts detailing men/material movement, General Layout and AHU Classifications, site MASTER FILE DOCUMENT NO. SUPERSEDES DOC. NO. EFFECTIVE FROM PAGE NO. SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 2 OF 51 Email: APPROVAL AND AUTHORIZATION SHEET Group Pharmaceuticals Limited site -Plot No. 41, KIADB Industrial Area, Malur- Kolar District 563 130 , Karnataka, INDIA Tel: +91-80-8151-234237; Fax: +91-80-8151-235084 Sl.

2 No. ACTIVITY NAME AND DESIGNATION DEPARTMENT SIGNATURE & DATE 1. Prepared By Mr. (Junior Officer QA & Regulatory) Quality Assurance 2. Checked By Mr. RAO (Sr. Production Manager) Production 3. Checked By Dr. PROMOD KUMAR JAIN (GM Corporate QC) Quality Control 4. Approved By Mr. RAJESH KAPOOR (GM Corporate QA & RA) Quality Assurance 5. Authorized By Dr. (Director Technical & Works) Overall In-Charge site MASTER FILE DOCUMENT NO. SUPERSEDES DOC. NO. EFFECTIVE FROM PAGE NO. SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 3 OF 51 GENERAL INFORMATION BRIEF INTRODUCTION OF THE ORGANIZATION Group Pharmaceuticals Limited is a closely held unlisted Company with its headquarters in Goregon west Mumbai and marketing office in Bangalore. Group Pharmaceuticals Limited was founded in 1980, It is engaged in manufacturing and marketing of Liquid (Oral, Syrups, suspensions, mouthwashes), External Preparations and cosmetics across the globe. Group Pharmaceuticals Limited strives to provide high quality pharmaceuticals that improve the health of the customers.

3 A team of personnel of various disciplines and pharmacists are working towards to meet the customers requirements and the objective of continuous improvement in quality. Group Pharmaceuticals Limited has complimentary production facilities, good marketing network and foreign collaborations too. The company has geared up to march ahead in facilitating its consumers with all the latest developments that has taken place in the pharma market with regards to Oral care healthcare and other Pharmaceutical products. This site MASTER file is related to GPL, dedicated to manufacturing of External Preparations (Creams, Ointments, Pastes, Gels, Lotions, Solutions) and Liquid (Oral, Syrups, suspensions, mouthwashes) Preparation, located at Plot No. 41, KIADB Industrial Area, Malur- Kolar District 563 130 Karnataka, INDIA; which is about 53 km from Bangalore City and 20 KM from Hoskote and the nearest railway station is at Malur which is km away from manufacturing plant.

4 LICENSABLE ACTIVITIES This site is licensed to manufacture Pharmaceutical products under the own manufacturing license number KTK/25/475/2001, KTK/28/339/2003, and KTK/32/268/2006 issued by Drugs Control Department, Government of Karnataka, India. OTHER MANUFACTURING ACTIVITIES AT THE site No other manufacturing activities are performed at the site , other than External Preparations (Creams, Ointments, Pastes, Gels, Lotions, Solutions) & Liquid (Oral, Syrups, suspensions, mouthwashes) Preparation. Formulations like eta-lactams and cephalosporins drug products are not stored or manufactured. site MASTER FILE DOCUMENT NO. SUPERSEDES DOC. NO. EFFECTIVE FROM PAGE NO. SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 4 OF 51 NAME AND ADDRESS Group Pharmaceutical Limited site Address: Plot No. 41, KIADB Industrial Area, Malur- Kolar District 563 130 , Karnataka, INDIA Phone: +91-(0)-8151-234237 Fax: +91-(0)-8151-235084 Web site : Registered Office: W/46 (B) MIDC, Tarapur 401 508 Thane District, INDIA Phone: +91-0- 2525-272108 Fax: +91-0- 2525-274036 Administrative Office Devraj Building A wing IV Floor, Goregaon west, Mumbai-62 INDIA Contact persons during and outside working hours Name of person Office Phone No.

5 Mobile No. Mr. Sunil Attavar Managing Director +91-(0) 080-23376766 +91-(0) 9342838923 Dr. Mahadev Director (Technical & Works) +91-(0) 8151-235220/234237 +91-(0) 9343661007 Mr. Sr. Manager Production +91-(0) 8151-235220/234237 +91-(0) 9342245271 Mr. Rajesh Kapoor GM Corporate QA & RA +91-(0) 8151-235220/234237 +91-(0) 9359889460 site MASTER FILE DOCUMENT NO. SUPERSEDES DOC. NO. EFFECTIVE FROM PAGE NO. SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 5 OF 51 TYPE OF PRODUCTS MANUFACTURED AT THE site . This site is licensed to manufacture Liquid (Oral, Syrups, suspensions, mouthwashes) & External Preparations-(Creams, Ointments, Pastes, Gels, Lotions, Solutions), No toxic or hazardous substances are handled at the site . The formulations manufactured at this site are for Human use only . LIST OF PRODUCTS MANUFACTURED Liquid (Oral, Syrups, suspensions, mouthwashes) & External Preparation--(Creams, Ointments, Pastes, Gels, Lotions, Solutions): Appendix-I.

6 DESCRIPTION OF THE site Group Pharmaceuticals Limited is located at KIADB industrial area, commissioned in and started its operation from 2002. The total area of the land is 4 Acres. The built up area is 42,000 Sq. ft. and is licensed to do Formulation and Testing for formulating External Preparation-(Creams, Ointments, Pastes, Gels Lotions, Solutions) & Liquid-(Oral, Syrups, suspensions, mouthwashes). The unit is located amidst lush green surroundings with non polluting industries like Garment Industry, Pharmaceutical Industry and Petrochemical Industry around. Near By: A) Hospital : Manasa Nursing Home Malur 2 km B) Fire Station : 40 km (Kolar Tamaka) Total Land Area = 4 acres Built up area = 42, 000 Square feet (approx.) Equivalent to 3,902 m2 (approx) Age of Building = New Facility ( March-2002) Type of Building = All concrete with Reinforced Cement Concrete Slabs. site MASTER FILE DOCUMENT NO.

7 SUPERSEDES DOC. NO. EFFECTIVE FROM PAGE NO. SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 6 OF 51 Area of various Modules and Sections Sr. No. Section Module I Area ( m2) 01 Manufacturing Area 02 Tube Filling and Sealing Area 03 General Washing Area TOTAL m2 Sr. No. Section Module II Area ( m2) 01 Manufacturing Area 02 Bottle washing Area 03 Bottle Filling and Sealing Area 04 General Washing Area TOTAL m2 Sr. No. Section Module I and Module II Area ( m2) 01 Packing Area TOTAL m2 Sr. No. Section Module III Area ( m2) 01 Manufacturing Area 02 Bottle washing Area 04 Bottle Filling and Sealing Area TOTAL m2 Sr. No. Section Module III Area ( m2) 01 Packing Area TOTAL m2 site MASTER FILE DOCUMENT NO. SUPERSEDES DOC. NO. EFFECTIVE FROM PAGE NO. SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 7 OF 51 NUMBER OF EMPLOYEES WORKING IN THE PLANT (Department Wise) DEPARTMENT CATEGORY NUMBER OF EMPLOYEES Production-Manufacturing Technical 14 Non-Technical Skilled -22 & Unskilled-206 Quality Control Technical 20 Non-Technical 06 Quality Assurance Technical 11 Non-Technical 01 Warehouse and Distribution Technical 09 Non-Technical 19 Engineering Technical 06 Non-Technical 09 House Keeping Supervisor 01 Labourer 29 Administration -- 12 Security -- 12 TOTAL EMPLOYEES Technical 61 Non-Technical 316 site MASTER FILE DOCUMENT NO.

8 SUPERSEDES DOC. NO. EFFECTIVE FROM PAGE NO. SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 8 OF 51 CONTRACT MANUFACTURE We at Group Pharmaceutical Limited follow Good Manufacturing Practice (GMP) as laid by World Health Organisation (WHO) in respect of manufacturing and testing of Pharmaceutical products. Group Pharmaceuticals Limited is currently manufacturing products of their own under the manufacturing licence KTK/25/475/2001, KTK/28/339/2003 & KTK/32/268/2006 and also on contract (LL & P to P) basis under respective manufacturing licence for the below said parties. Sr. No. PARTY NAME 01. Dr. Reddy s Laboratory Limited 02. Micro Labs Limited 03. Apex India Limited 04. Elan India Pvt. Limited 05. Medreich Pvt. Ltd. 06. Gepach International Limited 07. Cipla Limited 08. Remedia Therapeutic Limited 09. Sami Labs Limited 10. Medopharm 11. Srushti Pharmaceuticals Ltd. 12. Stiefel India Limited (GSK) 13. Pharmed 14. Fittydent International Gmbh 15. Zentiva Healthcare 16.

9 Eminent 17. Juggat Pharma 18. Sunways 19. Grandix site MASTER FILE DOCUMENT NO. SUPERSEDES DOC. NO. EFFECTIVE FROM PAGE NO. SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 9 OF 51 USE OF OUTSIDE EXPERTISE Company uses outside expertise for pest and rodent control, calibrations, filter integrity test, particle counting and need based training. Analysis of all the starting materials, intermediates and the finished products is carried out at the site by our own trained quality control staff. However, analytical services of the following external approved analytical laboratories are utilized during the breakdown or maintenance of any laboratory equipment. Their services are also utilized for speciality tests. Sl. No External Testing Laboratory Tel No. 01. Bangalore Test House- BTH No. 65, 20th main, Marenhalli, Vijayanagar BANGALORE 560 040 Phone: Fax: 080 23388895 080 23385979 02. Shiva Analyticals (India) ltd Plot No. 24D (P) and 34D, KIADB Industrial Area Hoskote 562 114 Phone: Fax: 080 5353961 03.

10 Sipra Labs Pvt Ltd. Space no. 7, 4th floor, Nilgiri Adidya Enclave Ameerpet, Hyderabad-560038 Phone: Fax: 040 23734720 04. Ashco Analytical Services 103, Diamond House, 6-3-83/D3/D4 Behind TOPAZ, Panjagutta, Hyderabad 500 082 Phone: Fax: 040 3406557 05. A to Z Pharmaceuitcals Pvt. Ltd. No. 12, Balaji Nagar , Ambattur, Chennai-600053 Phone: Fax: 042-26585811, 26585855 06. Medlar Laboratories Pvt. Ltd 2nd floor blding , Village Hariyali, Vikhroli(w) Mumbai-400083 Phone: Fax: 91-22-25786466, 25798330 07. Manisha Laboratories Pvt. Ltd 135-A Govt. Industrial estate . Charkop kandivali (W) Mumbai -400067 Phone: Fax: 28699888,28602292, 28683666 28602297 site MASTER FILE DOCUMENT NO. SUPERSEDES DOC. NO. EFFECTIVE FROM PAGE NO. SMF/GP/08 SMF/GP/07 APRIL 2010 PAGE 10 OF 51 Sl. No External Testing Laboratory Tel No. 08. Chemi Labs Plot No. 121. Opposite Murthy building, Prashanth Nagar, Kukatpally, Hyderabad-72 Phone: 040-23073496 09. General Analytical Laboratory , 17th cross, 13th main road, Malleswaram, Bangalore-560 055 Phone: Fax: 080-3343376, 3340395 080-3340395 Other services obtained from the external agencies are as follows; Pest and Rodent Control 1 Pesterad Services F-9, 1st Floor, Basco Court, Gandhi Bazar Main Road, Bangalore 560 004 India Phone: Fax: Mobile 91-080-26679604 91-080-26614101 98455 97918 Calibration of Critical Measuring, recording, weighing instruments.