01 2Alps Pharmaceutical Co., Ltd.
01 2Japanese Pharmacopoeia pentoxyverine citrate
01 2Japan
Japanese Pharmacopoeia Pentoxyverine Citrate
Registration Number : 221MF10228
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2009-10-19
Latest Date of Registration : 2009-10-19
Japanese Pharmacopoeia Pentoxyverine Citrate
Registration Number : 225MF10025
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2013-02-13
Latest Date of Registration : 2016-05-06
A Pentoxiverine citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentoxiverine citrate, including repackagers and relabelers. The FDA regulates Pentoxiverine citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentoxiverine citrate 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 Pentoxiverine citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pentoxiverine citrate supplier is an individual or a company that provides Pentoxiverine citrate active pharmaceutical ingredient (API) or Pentoxiverine citrate finished formulations upon request. The Pentoxiverine citrate suppliers may include Pentoxiverine citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Pentoxiverine citrate 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 Pentoxiverine citrate Drug Master File in Japan (Pentoxiverine citrate JDMF) empowers Pentoxiverine citrate 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 Pentoxiverine citrate JDMF during the approval evaluation for pharmaceutical products. At the time of Pentoxiverine citrate 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 Pentoxiverine citrate suppliers with JDMF on PharmaCompass.
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