Uk Mhra Gmp
DIVI'S LABORATORIES LIMITEDDIVI'S LABORATORIES LIMITED – UK MHRA GMP Certificate UK API 15298 Insp GMP 15298/358411-0001
Record Details
This Uk Mhra Gmp record concerns DIVI'S LABORATORIES LIMITED, with an inspection on December 13, 2016, issued by the MHRA, covering drugs.
- Company
- DIVI'S LABORATORIES LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- December 13, 2016
- Issued
- February 15, 2017
- MIA number
- UK API 15298
- Site address
- LINGOJIGUDEM VILLAGE, CHOUTUPPAL MANDAL, YADADRI BHUVANAGIRI DISTRICT, IN-508 252, INDIA
- Country
- INDIA
- Products
- Human Medicinal Products
- Manufacturing operations
- [1000007832] IOPAMIDOL [1000007298] ATOVAQUONE [1000000735] DESLORATADINE [2000007835] DEXTROMETHORPHAN HYDROBROMIDE [1000003241] DEXTROMETHORPHAN [1000013222] LEVETIRACETAM [1000000402] NABUMETONE [1000009701] NAPROXEN [2000008310] PROGUANIL HYDROCHLORIDE [2000005649] QUETIAPINE FUMARATE [1000008495] TELMISARTAN [1000009498] LAMOTRIGINE [2000007961] VALACICLOVIR HYDROCHLORIDE [2000008037] ZOLPIDEM TARTRATE [1000009387] SULPHASALAZINE Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES IOPAMIDOL 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) Crystallization 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying and sieving are carried out in-house at Divis Laborato 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) ATOVAQUONE 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) Precipitation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying and micronisation are carried out in-house at Divis La 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) DESLORATADINE 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) Crystallization 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying, milling, sieving and micronisation is carried out in- 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) DEXTROMETHORPHAN HYDROBROMIDE 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) Crystallization 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying, milling, micronisation & sieving are carried out in-ho 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) DEXTROMETHORPHAN 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) Crystallization 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying and sieving are carried out in-house at Divis Laborato 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) LEVETIRACETAM 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) Crystallization 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying, milling, micronisation, sieving are carried out in-hou 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) 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) Crystallization 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing i.e like drying, micronisation, sieving are carried out in-house at Divi 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) NAPROXEN 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) Precipitation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying, milling, micronisation, sieving are carried out in-hou 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) PROGUANIL 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) Crystallization 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying, milling, micronisation & sieving are carried out in-ho 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) QUETIAPINE FUMARATE 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) Crystallization 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying, micronisation & sieving are carried out in-house at Di 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) TELMISARTAN 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) Precipitation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying, milling, micronisation, sieving are carried out in-hou 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) LAMOTRIGINE 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) Precipitation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying is carried out in-house at Divis Laboratories Limited. 3.5.2 Primary Packaging 3.5.3 Secondary Packaging 3.6 Quality Control Testing 3.6.1 Physical / Chemical testing VALACICLOVIR 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) Crystallization 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying, milling & sieving are carried out in-house at Divis L 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) ZOLPIDEM TARTRATE 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) Crystallization 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying & sieving are carried out in-house at Divis Laboratori 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) SULPHASALAZINE 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) crystallization 3.5 General Finishing Steps 3.5.1 Physical Processing Steps All the physical processing steps i.e drying & sieving are carried out in-house at Divis Laboratori 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 Inspection also covered manufacture of the following intermediates: FAPE, R-Amine, Sulphazine, Thiol Acid. The reference to Lamotrigine on the GMP certificate refers to intermediate only.
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