01 1Alkermes, Inc.
01 1Medisorb 7525 DL JN1
01 1Ireland
Registration Number : 218MF20003
Registrant's Address : 852 Winter Street, Waltham, MA 02451, USA
Initial Date of Registration : 2006-11-10
Latest Date of Registration : 2023-02-02
A Glycolide - lactide copolymer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glycolide - lactide copolymer, including repackagers and relabelers. The FDA regulates Glycolide - lactide copolymer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glycolide - lactide copolymer API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Glycolide - lactide copolymer manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glycolide - lactide copolymer supplier is an individual or a company that provides Glycolide - lactide copolymer active pharmaceutical ingredient (API) or Glycolide - lactide copolymer finished formulations upon request. The Glycolide - lactide copolymer suppliers may include Glycolide - lactide copolymer API manufacturers, exporters, distributors and traders.
click here to find a list of Glycolide - lactide copolymer suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Glycolide - lactide copolymer Drug Master File in Japan (Glycolide - lactide copolymer JDMF) empowers Glycolide - lactide copolymer API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Glycolide - lactide copolymer JDMF during the approval evaluation for pharmaceutical products. At the time of Glycolide - lactide copolymer JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Glycolide - lactide copolymer suppliers with JDMF on PharmaCompass.
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