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