01 1Andhra Organics Limited
01 1Trimethoprim
01 1India
Registration Number : 303MF10098
Registrant's Address : Plot No. 08,S. V Co-op. Industrial estate I. D. A, Jeedimetla,Hyderabad-500055,T. S, ...
Initial Date of Registration : 2021-06-22
Latest Date of Registration : 2024-05-15
A Trimethoprim manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trimethoprim, including repackagers and relabelers. The FDA regulates Trimethoprim manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trimethoprim 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 Trimethoprim manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trimethoprim supplier is an individual or a company that provides Trimethoprim active pharmaceutical ingredient (API) or Trimethoprim finished formulations upon request. The Trimethoprim suppliers may include Trimethoprim API manufacturers, exporters, distributors and traders.
click here to find a list of Trimethoprim 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 Trimethoprim Drug Master File in Japan (Trimethoprim JDMF) empowers Trimethoprim 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 Trimethoprim JDMF during the approval evaluation for pharmaceutical products. At the time of Trimethoprim 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 Trimethoprim suppliers with JDMF on PharmaCompass.
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