Uk Mhra Gmp
YONSUNG FINE CHEMICALS COMPANY LIMITEDYONSUNG FINE CHEMICALS COMPANY LIMITED – UK MHRA GMP Certificate UK GMP 34460 Insp GMP 34460/720129-0006[H]
Record Details
This Uk Mhra Gmp record concerns YONSUNG FINE CHEMICALS COMPANY LIMITED, with an inspection on April 25, 2017, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- April 25, 2017
- Issued
- May 31, 2017
- MIA number
- UK GMP 34460
- Site address
- 207 SUJEONG-RO, JANGAN-MYEON, HWASEONG-SI, GYEONGGI-DO, KR-18581, SOUTH KOREA
- Country
- SOUTH KOREA
- Products
- Human Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.2 ] Non-sterile products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.17 ] Other non-sterile medicinal productsPremix of Misoprostol and Hypromellose 1% Dispersion [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical
- Restrictions
- This assessment of GMP compliance is being performed under the INTERNATIONAL COALITION OF MEDICINES REGULATORY AUTHORITIES (ICMRA), Good Manufacturing Practice (GMP) Project, Framework Implementation: Phase 2 Model : Confirmation that GMP certificate issued based upon inspection data from Korean MFDS and additional information provided by the company. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products API blending with Hypromellose.
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ID · a4d952a4-c6da-4b8d-9c7f-319422cff871
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