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
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PharmaCompass offers a list of Glycolide - lactide copolymer API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Glycolide - lactide copolymer manufacturer or Glycolide - lactide copolymer supplier for your needs.
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PharmaCompass also assists you with knowing the Glycolide - lactide copolymer API Price utilized in the formulation of products. Glycolide - lactide copolymer API Price is not always fixed or binding as the Glycolide - lactide copolymer Price is obtained through a variety of data sources. The Glycolide - lactide copolymer Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Atrigel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atrigel, including repackagers and relabelers. The FDA regulates Atrigel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atrigel 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 Atrigel supplier is an individual or a company that provides Atrigel active pharmaceutical ingredient (API) or Atrigel finished formulations upon request. The Atrigel suppliers may include Atrigel API manufacturers, exporters, distributors and traders.
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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 Atrigel Drug Master File in Japan (Atrigel JDMF) empowers Atrigel 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 Atrigel JDMF during the approval evaluation for pharmaceutical products. At the time of Atrigel JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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