01 1Shiratori Pharmaceutical Co., Ltd.
01 1Japanese Pharmacopoeia hydrochloric acid noscapine production dedicated
01 1Japan
Japanese Pharmacopoeia Noscapine Hydrochloride For manufacturing only
Registration Number : 217MF10316
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2005-07-14
Latest Date of Registration : 2009-10-29
A Noscapine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Noscapine HCl, including repackagers and relabelers. The FDA regulates Noscapine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Noscapine HCl 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 Noscapine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Noscapine HCl supplier is an individual or a company that provides Noscapine HCl active pharmaceutical ingredient (API) or Noscapine HCl finished formulations upon request. The Noscapine HCl suppliers may include Noscapine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Noscapine HCl 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 Noscapine HCl Drug Master File in Japan (Noscapine HCl JDMF) empowers Noscapine HCl 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 Noscapine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Noscapine HCl 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 Noscapine HCl suppliers with JDMF on PharmaCompass.
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