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
A Boron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Boron, including repackagers and relabelers. The FDA regulates Boron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Boron 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 supplier is an individual or a company that provides Boron active pharmaceutical ingredient (API) or Boron finished formulations upon request. The Boron suppliers may include Boron API manufacturers, exporters, distributors and traders.
click here to find a list of Boron 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 Boron Drug Master File in Japan (Boron JDMF) empowers Boron 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Boron 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 suppliers with JDMF on PharmaCompass.
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