Uk Mhra Gmp
LUPIN LIMITEDLUPIN LIMITED – UK MHRA GMP Certificate UK GMP 25315 Insp GMP 23158/39047-0009 [H]
Record Details
This Uk Mhra Gmp record concerns LUPIN LIMITED, with an inspection on September 10, 2012, issued by the MHRA, covering drugs.
- Company
- LUPIN LIMITED
- Compliance status
- GMPC
- Certificate type
- GMP
- Inspection date
- September 10, 2012
- Issued
- August 15, 2016
- MIA number
- UK GMP 25315
- Site address
- 198-202 NEW INDUSTRIAL AREA NO. 2, MANDIDEEP, DISTRICT RAISEN, IN-462 046, 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) [ 1.1.1.5 ] Solids and implants [ 1.2 ] Non-sterile products [ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms) [ 1.2.1.1 ] Capsules, hard shell [ 1.2.1.13 ] Tablets [ 1.2.1.17 ] Other non-sterile medicinal productsDry syrups for oral administration after reconstitution [ 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 [ 1.5 ] Packaging [ 1.5.2 ] Secondary packaging [ 1.6 ] Quality control testing [ 1.6.1 ] Microbiological: sterility [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical
- Restrictions
- 15-Aug-2016 In accordance with the Compilation of Community Procedures ( EMA/572454/2014 Rev 17), the MHRA as the issuing authority confirm that this certificate based on the inspection conducted 2012-Sep-10 remains valid and can be utilised to support regulatory submissions until a subsequent inspection has been concluded. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products The inspection covered sterile APIs manufactured in 'Phase 3', sterile powder filling operations in 'Phase 2', and dosage form manufacture in the 'Orals Facility'. The inspection covered the manufacture of non-sterile and sterile dosage forms referred to in preceding sections of the certificate. The manufacture of sterile APIs was also covered within the scope of this inspection. Sterile APIs for EU supply were covered by this inspection.
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