Uk Mhra Gmp
STRIDES SHASUN LIMITEDSTRIDES SHASUN LIMITED – UK MHRA GMP Certificate UK API 20003 Insp GMP 20003/14223367-0001
Record Details
This Uk Mhra Gmp record concerns STRIDES SHASUN LIMITED, with an inspection on January 9, 2017, issued by the MHRA, covering drugs.
- Company
- STRIDES SHASUN LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- January 9, 2017
- Issued
- April 25, 2017
- MIA number
- UK API 20003
- Site address
- A-1/B SIPCOT INDUSTRIAL COMPLEX, KUDIKADU VILLAGE, CUDDALORE, IN-607 005, INDIA
- Country
- INDIA
- Products
- Human Medicinal Products
- Manufacturing operations
- [2000007813] RANITIDINE HYDROCHLORIDE [2000007870] VENLAFAXINE HYDROCHLORIDE [1000000402] NABUMETONE [1000007380] GABAPENTIN [1000007944] OLANZAPINE [1000009671] NIZATIDINE Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES RANITIDINE HYDROCHLORIDE 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) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, Milling & sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing VENLAFAXINE HYDROCHLORIDE 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) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, Milling & sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing NABUMETONE 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) Crystallisation & Purification 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, Milling & sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing GABAPENTIN 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) Crystallisation & Purification 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, Milling & sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing OLANZAPINE 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) Crystallisation & Purification 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, Milling & sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing NIZATIDINE 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) Crystallisation & Purification 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, Milling & sieving 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 Certification DOES NOT include Production Block 1.
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