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