Uk Mhra Gmp
ALEMBIC PHARMACEUTICALS LIMITED (API UNIT-III)ALEMBIC PHARMACEUTICALS LIMITED (API UNIT-III) – UK MHRA GMP Certificate UK API 40420 Insp GMP 40420/11556777-0002
Record Details
This Uk Mhra Gmp record concerns ALEMBIC PHARMACEUTICALS LIMITED (API UNIT-III), with an inspection on November 20, 2014, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- November 20, 2014
- Issued
- July 15, 2015
- MIA number
- UK API 40420
- Site address
- UNIT III, PLOT NO 842-843, VILLAGE KARAKHADI, VADODARA, TALUKA PADRA, IN-391450, INDIA
- Country
- INDIA
- Products
- Human Medicinal Products
- Manufacturing operations
- [3000018078] TADALAFIL PH.EUR. [4000014258] DULOXETINE HYDROCHLORIDE PH.EUR. Active Substances 3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES TADALAFIL PH.EUR. 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) Purification 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Micronisation 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) DULOXETINE HYDROCHLORIDE PH.EUR. 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) Hydrochloride salt formation 3.5 General Finishing Steps 3.5.1 Physical Processing Steps Micronisation 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)
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ID · 30db3444-3f07-4f8e-b78d-918d1c431739
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