01 1Abbott Healthcare Products B. V.
01 1Dydrogesterone
01 1U.S.A
Registration Number : 218MF10211
Registrant's Address : C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Initial Date of Registration : 2006-02-16
Latest Date of Registration : 2022-07-13
A Dydrogesterone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dydrogesterone, including repackagers and relabelers. The FDA regulates Dydrogesterone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dydrogesterone 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 Dydrogesterone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dydrogesterone supplier is an individual or a company that provides Dydrogesterone active pharmaceutical ingredient (API) or Dydrogesterone finished formulations upon request. The Dydrogesterone suppliers may include Dydrogesterone API manufacturers, exporters, distributors and traders.
click here to find a list of Dydrogesterone 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 Dydrogesterone Drug Master File in Japan (Dydrogesterone JDMF) empowers Dydrogesterone 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 Dydrogesterone JDMF during the approval evaluation for pharmaceutical products. At the time of Dydrogesterone 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 Dydrogesterone suppliers with JDMF on PharmaCompass.
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