DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1M/s Dr. Reddy's Laboratories
02 1Gland Pharma Limited
03 1M/s. Natco Pharma Ltd,
04 1Mis Biocon Limited
01 1Glatiramer Acetate (IH)
02 3Glatiramer Acetate IH
01 1WC-0014
02 1WC-0038n
03 1WC-0067
04 1WC-0427A3-4
01 4India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...
Date of Issue : 2022-07-06
Valid Till : 2025-08-04
Written Confirmation Number : WC-0038n
Address of the Firm : Plot no. 213-215 & 21618, IDA Phase II, Pashamylaram, Sangareddy (District), Tel...
Date of Issue : 2022-08-04
Valid Till : 2025-03-04
Written Confirmation Number : WC-0427A3-4
Address of the Firm : Plot No.49 & 50, J.N. Pharma City, Parawada (M), Visakhapatnam - 531019, Andhra ...
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0014
Address of the Firm : Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India
A Copaxone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Copaxone, including repackagers and relabelers. The FDA regulates Copaxone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Copaxone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Copaxone supplier is an individual or a company that provides Copaxone active pharmaceutical ingredient (API) or Copaxone finished formulations upon request. The Copaxone suppliers may include Copaxone API manufacturers, exporters, distributors and traders.
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A Copaxone written confirmation (Copaxone WC) is an official document issued by a regulatory agency to a Copaxone manufacturer, verifying that the manufacturing facility of a Copaxone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Copaxone APIs or Copaxone finished pharmaceutical products to another nation, regulatory agencies frequently require a Copaxone WC (written confirmation) as part of the regulatory process.
click here to find a list of Copaxone suppliers with Written Confirmation (WC) on PharmaCompass.
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