01 1Biocon Limited
01 1ATV-I Boronate
01 1India
Registration Number : 223MF10033
Registrant's Address : 20th KM, Hosur Road, Electronics City-560100, Bengaluru, India
Initial Date of Registration : 2011-03-03
Latest Date of Registration : 2011-03-03
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PharmaCompass offers a list of Boron API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Boron manufacturer or Boron supplier for your needs.
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A Boron Proteinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Boron Proteinate, including repackagers and relabelers. The FDA regulates Boron Proteinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Boron Proteinate 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 Boron Proteinate supplier is an individual or a company that provides Boron Proteinate active pharmaceutical ingredient (API) or Boron Proteinate finished formulations upon request. The Boron Proteinate suppliers may include Boron Proteinate API manufacturers, exporters, distributors and traders.
click here to find a list of Boron Proteinate 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 Boron Proteinate Drug Master File in Japan (Boron Proteinate JDMF) empowers Boron Proteinate 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 Boron Proteinate JDMF during the approval evaluation for pharmaceutical products. At the time of Boron Proteinate 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 Boron Proteinate suppliers with JDMF on PharmaCompass.
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