Uk Mhra Gmp
MYLAN LABORATORIES LIMITED - ONCO THERAPIES (OTL)MYLAN LABORATORIES LIMITED - ONCO THERAPIES (OTL) – UK MHRA GMP Certificate UK GMP 20807 Insp GMP 20807/1275261-0007[H]
Record Details
This Uk Mhra Gmp record concerns MYLAN LABORATORIES LIMITED - ONCO THERAPIES (OTL), with an inspection on December 11, 2017, issued by the MHRA, covering drugs.
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- December 11, 2017
- Issued
- March 29, 2018
- MIA number
- UK GMP 20807
- Site address
- PLOT NO 284/B, BOMMASANDRA JIGANI LINK ROAD INDUSTRIAL AREA, JIGANI HOBLI, ANEKAL TALUK, BANGALORE, IN-560105, INDIA
- Country
- INDIA
- Products
- Human Medicinal Products
- Manufacturing operations
- 1. MANUFACTURING OPERATIONS [ 1.1 ] Sterile Products [ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms) [ 1.1.1.2 ] Lyophilisates [ 1.1.1.4 ] Small volume liquids [ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms) [ 1.1.2.3 ] Small volume liquids [ 1.4 ] Other products or manufacturing activity [ 1.4.2 ] Sterilisation of active substances/excipients/finished products: [ 1.4.2.1 ] Filtration [ 1.4.2.2 ] Dry heat [ 1.4.2.3 ] Moist heat [ 1.6 ] Quality control testing [ 1.6.1 ] Microbiological: sterility [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical
- Restrictions
- GMP certification for the site restricted to manufacturing within Suites 1 and 2 (as Suite 3 has been decommissioned).
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ID · c0fdd027-e299-4ed6-a7ed-12499d34b252
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