01 1Aurobindo Pharma Limited
01 1Pivmecillinam hydrochloride
01 1India
Registration Number : 220MF10224
Registrant's Address : Plot No. 2, Maitrivihar, Ameerprt, Hyderabad, Andhra Pradesh, India 500-038
Initial Date of Registration : 2008-11-10
Latest Date of Registration : 2008-11-10
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A Amdinocillin Pivoxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amdinocillin Pivoxil, including repackagers and relabelers. The FDA regulates Amdinocillin Pivoxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amdinocillin Pivoxil 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 Amdinocillin Pivoxil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Amdinocillin Pivoxil supplier is an individual or a company that provides Amdinocillin Pivoxil active pharmaceutical ingredient (API) or Amdinocillin Pivoxil finished formulations upon request. The Amdinocillin Pivoxil suppliers may include Amdinocillin Pivoxil API manufacturers, exporters, distributors and traders.
click here to find a list of Amdinocillin Pivoxil 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 Amdinocillin Pivoxil Drug Master File in Japan (Amdinocillin Pivoxil JDMF) empowers Amdinocillin Pivoxil 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 Amdinocillin Pivoxil JDMF during the approval evaluation for pharmaceutical products. At the time of Amdinocillin Pivoxil JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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