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01 1TAPI Czech Industries s. r. o.
02 1Lek Pharmaceuticals d. d.
01 2Bromocriptine mesylate
01 1Israel
02 1Slovenia
Registration Number : 218MF10573
Registrant's Address : Ostravska 305/29, Komarov, 747 70 Opava, Czech Republic
Initial Date of Registration : 2006-06-15
Latest Date of Registration : 2024-10-31
Registration Number : 221MF10054
Registrant's Address : Verovskova 57, SI-1526 Ljubljana, Slovenia
Initial Date of Registration : 2009-03-16
Latest Date of Registration : 2009-03-16
A Bromocriptine Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromocriptine Mesylate, including repackagers and relabelers. The FDA regulates Bromocriptine Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromocriptine Mesylate 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 Bromocriptine Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bromocriptine Mesylate supplier is an individual or a company that provides Bromocriptine Mesylate active pharmaceutical ingredient (API) or Bromocriptine Mesylate finished formulations upon request. The Bromocriptine Mesylate suppliers may include Bromocriptine Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Bromocriptine Mesylate 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 Bromocriptine Mesylate Drug Master File in Japan (Bromocriptine Mesylate JDMF) empowers Bromocriptine Mesylate 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 Bromocriptine Mesylate JDMF during the approval evaluation for pharmaceutical products. At the time of Bromocriptine Mesylate 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 Bromocriptine Mesylate suppliers with JDMF on PharmaCompass.
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