Uk Mhra Gmp
WOCKHARDT LIMITEDWOCKHARDT LIMITED – UK MHRA GMP Certificate UK API 8913 Insp GMP 8913/18322-0006
Record Details
This Uk Mhra Gmp record concerns WOCKHARDT LIMITED, with an inspection on November 11, 2013, issued by the MHRA, covering drugs.
- Company
- WOCKHARDT LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- November 11, 2013
- Issued
- April 16, 2014
- MIA number
- UK API 8913
- Site address
- L-1, MIDC, JALGAON ROAD, CHIKALTHANA, AURANGABAD, IN-431 210, INDIA
- Country
- INDIA
- Products
- Human Medicinal Products
- Manufacturing operations
- [4000006734] OXYBUTYNIN CHLORIDE [2000016830] CHLOROTHIAZIDE SODIUM [1000009945] EPINEPHRINE [2000010996] BETHANECHOL CHLORIDE [4000011693] PRAMIPEXOLE DIHYDROCHLORIDE [4000013915] WCK 771 [1000002661] NADIFLOXACIN [2000016831] GATIFLOXACIN HEMIHYDRATE [1000003230] ZONISAMIDE [1000006787] CAPTOPRIL [2000016014] FESOTERODINE FUMARATE [2000018014] EPINEPHRINE BITARTRATE [2000015746] SAXAGLIPTIN HYDROCHLORIDE [3000017469] ZOLPIDEM BASE Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES OXYBUTYNIN CHLORIDE 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 and sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) CHLOROTHIAZIDE 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) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, milling and sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) EPINEPHRINE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying and sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) BETHANECHOL CHLORIDE 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 and seiving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) PRAMIPEXOLE DIHYDROCHLORIDE 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 and sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) WCK 771 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, milling and sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) NADIFLOXACIN 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 and sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing GATIFLOXACIN HEMIHYDRATE 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 and sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) ZONISAMIDE 3.1 Manufacture of Active Substance by Chemical Synthesis 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, seiving and blending 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) CAPTOPRIL 3.1 Manufacture of Active Substance by Chemical Synthesis 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 and blending 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) FESOTERODINE FUMARATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying, milling and sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing EPINEPHRINE BITARTRATE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying and sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing 3.6.2 Microbiological testing (excluding sterility testing) SAXAGLIPTIN HYDROCHLORIDE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.1.3 Salt Formation/Purification steps (eg. Crystallisation) Crystallisation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying and sieving 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing ZOLPIDEM BASE 3.1 Manufacture of Active Substance by Chemical Synthesis 3.1.1 Manufacture Of Active Substance Intermediates 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Drying 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 This inspection covered the API manufacturing facilitiies only in L1 Chikalthna in process houses PH I, II, IV V and VI
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