Uk Mhra Gmp
NANJING KING FRIEND BIOCHEMICAL PHARMACEUTICAL COMPANY LIMITEDNANJING KING FRIEND BIOCHEMICAL PHARMACEUTICAL COMPANY LIMITED – UK MHRA GMP Certificate UK API 44519 Insp GMP 44519/12076689-0001 [V]
Record Details
This Uk Mhra Gmp record concerns NANJING KING FRIEND BIOCHEMICAL PHARMACEUTICAL COMPANY LIMITED, with an inspection on September 24, 2018, issued by the MHRA, covering veterinary.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- September 24, 2018
- Issued
- November 6, 2018
- MIA number
- UK API 44519
- Site address
- MA-010-1, NANJING HIGH & NEW TECHNOLOGY DEVELOPMENT ZONE, NANJING, CN-210 061, CHINA
- Country
- CHINA
- Products
- Veterinary Medicinal Products
- Manufacturing operations
- [2000007085] ENOXAPARIN SODIUM Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES ENOXAPARIN SODIUM 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.2 Manufacture Of Crude Active Substance 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Oxidation, filtration, precipitation, dehydration 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, milling 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products LMWH Workshop 3 and associated storage areas and utilities IPC testing and testing of intermediates only at this site. Enoxaparin Sodium only
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ID · a725845c-7861-41b3-a6a2-b612422d5fe9
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