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Uk Mhra Gmp
•KOPRAN LIMITED•September 19, 2016

KOPRAN LIMITED – UK MHRA GMP Certificate UK GMP 14967 Insp GMP 14967/5900-0012[H]

Record Details

This Uk Mhra Gmp record concerns KOPRAN LIMITED, with an inspection on September 19, 2016, issued by the MHRA, covering drugs.

Company
KOPRAN LIMITED
Compliance status
GMPC
Certificate type
GMP
Inspection date
September 19, 2016
Issued
January 29, 2021
MIA number
UK GMP 14967
Site address
VILLAGE SAVROLI, KHALAPUR, RAIGAD, IN-410202, INDIA
Country
INDIA
Products
Human Medicinal Products
Manufacturing operations
1. MANUFACTURING OPERATIONS [ 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 [ 1.2.1.8 ] Other solid dosage forms [ 1.2.1.13 ] Tablets [ 1.6 ] Quality control testing [ 1.6.2 ] Microbiological: non-sterility [ 1.6.3 ] Chemical/Physical
Restrictions
This updated certificate is based on an inspection carried out in September 2016 - see front page for dates. Certificate applies to Plant I (Beta lactams) and Plant II (non beta lactams). In Plant II only blister packaging line 3 and bulk/bottle packaging line 2 are included in the scope of this certificate In Plant I only blister packaging line 2 is included in the scope of this certificate This updated certificate is based on an inspection carried out in September 2016 - see front page of GMP certificate for details. Any restrictions related to the scope of this certificate: Restrictions Building Room Line/equipment QC Testing Products Certificate applies to Plant I (Beta lactams) and Plant II (non beta lactams) In Plant II only blister packaging line 3 and bulk/bottle packaging line 2 are included in the scope of this certificate In Plant I only blister packaging line 2 is included in the scope of this certificate This updated certificate is based on an inspection carried out in September 2016 - see front page of GMP certificate for details.
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ID · a680fa2f-ae00-4ace-a486-0ae5e3042592

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