01 1Ipca Laboratories Limited
01 1BENZARONE
01 1India
Registration Number : 218MF10840
Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (West), Mumbai 400 067, India
Initial Date of Registration : 2006-10-20
Latest Date of Registration : 2006-10-20
A Benzarone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzarone, including repackagers and relabelers. The FDA regulates Benzarone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzarone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Benzarone supplier is an individual or a company that provides Benzarone active pharmaceutical ingredient (API) or Benzarone finished formulations upon request. The Benzarone suppliers may include Benzarone API manufacturers, exporters, distributors and traders.
click here to find a list of Benzarone 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 Benzarone Drug Master File in Japan (Benzarone JDMF) empowers Benzarone 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 Benzarone JDMF during the approval evaluation for pharmaceutical products. At the time of Benzarone 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 Benzarone suppliers with JDMF on PharmaCompass.
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