01 1Harman Finochem Ltd.
01 1Clofazimine
01 1India
Registration Number : 306MF10099
Registrant's Address : 107-A, Vinay Bhavya Complex, 159-A, C. S. T Road, Kalina, Santa Cruz (East), Mumbai-4...
Initial Date of Registration : 2024-07-17
Latest Date of Registration : 2024-07-17
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A Hansepran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hansepran, including repackagers and relabelers. The FDA regulates Hansepran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hansepran 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 Hansepran manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hansepran supplier is an individual or a company that provides Hansepran active pharmaceutical ingredient (API) or Hansepran finished formulations upon request. The Hansepran suppliers may include Hansepran API manufacturers, exporters, distributors and traders.
click here to find a list of Hansepran suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Hansepran Drug Master File in Japan (Hansepran JDMF) empowers Hansepran 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 Hansepran JDMF during the approval evaluation for pharmaceutical products. At the time of Hansepran 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 Hansepran suppliers with JDMF on PharmaCompass.
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