01 1Daiwa Pharmaceutical Industries Co., Ltd.
01 1Pirenzepine hydrochloride hydrate (production only)
01 1Japan
Pirenzepine hydrochloride hydrate (for manufacturing purposes only)
Registration Number : 222MF10250
Registrant's Address : 2-3-5 Shimookui, Toyama City, Toyama Prefecture
Initial Date of Registration : 2010-10-28
Latest Date of Registration : 2010-10-28
A Pirenzepine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pirenzepine, including repackagers and relabelers. The FDA regulates Pirenzepine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pirenzepine 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 Pirenzepine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pirenzepine supplier is an individual or a company that provides Pirenzepine active pharmaceutical ingredient (API) or Pirenzepine finished formulations upon request. The Pirenzepine suppliers may include Pirenzepine API manufacturers, exporters, distributors and traders.
click here to find a list of Pirenzepine 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 Pirenzepine Drug Master File in Japan (Pirenzepine JDMF) empowers Pirenzepine 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 Pirenzepine JDMF during the approval evaluation for pharmaceutical products. At the time of Pirenzepine 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 Pirenzepine suppliers with JDMF on PharmaCompass.
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