01 1Exelead, Inc.
01 1Ella peg Ade Ma Ze
01 1U.S.A
Registration Number : 230MF10020
Registrant's Address : 6925 Guion Road, Indianapolis, IN 46268, USA
Initial Date of Registration : 2018-02-05
Latest Date of Registration : 2024-10-16
A Elapegademase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elapegademase, including repackagers and relabelers. The FDA regulates Elapegademase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elapegademase API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Elapegademase supplier is an individual or a company that provides Elapegademase active pharmaceutical ingredient (API) or Elapegademase finished formulations upon request. The Elapegademase suppliers may include Elapegademase API manufacturers, exporters, distributors and traders.
click here to find a list of Elapegademase 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 Elapegademase Drug Master File in Japan (Elapegademase JDMF) empowers Elapegademase 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 Elapegademase JDMF during the approval evaluation for pharmaceutical products. At the time of Elapegademase 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 Elapegademase suppliers with JDMF on PharmaCompass.
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