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 Polyglactin 910 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polyglactin 910, including repackagers and relabelers. The FDA regulates Polyglactin 910 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polyglactin 910 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 Polyglactin 910 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polyglactin 910 supplier is an individual or a company that provides Polyglactin 910 active pharmaceutical ingredient (API) or Polyglactin 910 finished formulations upon request. The Polyglactin 910 suppliers may include Polyglactin 910 API manufacturers, exporters, distributors and traders.
click here to find a list of Polyglactin 910 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 Polyglactin 910 Drug Master File in Japan (Polyglactin 910 JDMF) empowers Polyglactin 910 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 Polyglactin 910 JDMF during the approval evaluation for pharmaceutical products. At the time of Polyglactin 910 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 Polyglactin 910 suppliers with JDMF on PharmaCompass.
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