Licence Summary for Medicinal Product - Manufacturer Licence 1.

Licence/Permit/Certificate/Listing/Notification Summary
1.1Licence/Permit/Certificate/Listing Notification Type : 1.2Licence/Permit/Certificate/Listing Notification No : 1.3 Company Name : 1.4 Approved Date : 1.5 Expiry Date : Medicinal Product - Manufacturer Licence MLMP1100002 MSD INTERNATIONAL GMBH (SINGAPORE BRANCH) 05/01/2011 04/01/2013

2. Licence Information
2.1 Approved Business premise : 60, TUAS WEST DRIVE #- SINGAPORE 638413 2.2 Approved Manufacturing site(s) 1) 60 TUAS WEST DRIVE SINGAPORE 638413 : 1) 60 TUAS WEST DRIVE SINGAPORE 638413 2.3 Approved warehouse(s) : 2) 7 GUL CIRCLE LEVEL 01 SINGAPORE 629563 2.4.1.1 Name of person in charge of SHARDA ANUJ KUMAR BALDEVKRISHAN production : 2.4.1.2 Designation of person in IPT Leader charge of production : 2.5.1.1 Name of person in charge of Chen Siang Ling, Belinda quality control : 2.5.1.2 Designation of person in Senior Quality Leader charge of quality control : 2.6.1.1 Name of approved contract testing laboratory : 2.6.1.2 Address of the laboratory : 2.6.1.3 Type of Test Performed by the Laboratory : 2.7 The manufacturing plant in which the products are manufactured, whether to be sold or distributed within Singapore or to be exported, is subjected to inspections at suitable intervals. 2.8 It is certified that the manufacturer has maintained an overall acceptable level of compliance with the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products (Part I) relating to finished products, which encompasses all the recommendations of the World Health Organization (WHO) in relation to GMP. 2.9 Approved Dosage Form : 2.9.1 Manufacture : 1) Sterile powders for injection 2.9.2 Primary Assembly : NIL 2.9.3 Secondary Assembly : NIL

3. The Licence/Permit/Certificate/Listing/Notification is issued subject to the following condition

3.1 3.2 3.3 3.4 3.5 3.6 You are not authorised to manufacture/assemble any cytotoxic medicinal product. You are not authorised to manufacture/assemble non-medicinal products containing toxic and hazardous substances in the same premises used for the manufacture/assemble of medicinal products. You are not authorised to manufacture/assemble any preparation containing cephalosporins. You are not authorised to manufacture/assemble any preparation containing penicillins. You are not authorised to manufacture/assemble any preparation containing hormones. You are not authorised to manufacture/assemble any preparation containing steroids.

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The above information is current as of the date of print : 21/06/2012 The validity of the information on this document may be verified with the licensing authority stated on this document This is a computer generated document, no signature is required.

Audit & Licensing Division Health Products Regulation Group Health Sciences Authority Tel :65-68663510, Fax :65-64789068, or Email :hsa_gmp@hsa.gov.sg

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