01 1RPG Life Sciences Limited
02 1Tokuyama Corporation
01 1Japanese Pharmacopoeia propantheline bromide (production only)
02 1Propantheline Bromide
01 1India
02 1Japan
Registration Number : 303MF10144
Registrant's Address : RPG House, 463, Dr. Annie Besant Road, Worli, Mumbai 400030, India.
Initial Date of Registration : 2021-09-09
Latest Date of Registration : 2024-06-18
Japanese Pharmacopoeia Propantheline Bromide (For manufacturing only)
Registration Number : 221MF10068
Registrant's Address : 1-1 Mikage-cho, Shunan City, Yamaguchi Prefecture
Initial Date of Registration : 2009-03-26
Latest Date of Registration : 2009-03-26
A Propantheline Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Propantheline Bromide, including repackagers and relabelers. The FDA regulates Propantheline Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Propantheline Bromide 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 Propantheline Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Propantheline Bromide supplier is an individual or a company that provides Propantheline Bromide active pharmaceutical ingredient (API) or Propantheline Bromide finished formulations upon request. The Propantheline Bromide suppliers may include Propantheline Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Propantheline Bromide 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 Propantheline Bromide Drug Master File in Japan (Propantheline Bromide JDMF) empowers Propantheline Bromide 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 Propantheline Bromide JDMF during the approval evaluation for pharmaceutical products. At the time of Propantheline Bromide 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 Propantheline Bromide suppliers with JDMF on PharmaCompass.
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