01 1LUPIN LIMITED.
01 1Abacavir sulfate
01 1India
Registration Number : 229MF10171
Registrant's Address : Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai 4...
Initial Date of Registration : 2017-08-28
Latest Date of Registration : 2020-08-18
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A 1592U89 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1592U89, including repackagers and relabelers. The FDA regulates 1592U89 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1592U89 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 1592U89 supplier is an individual or a company that provides 1592U89 active pharmaceutical ingredient (API) or 1592U89 finished formulations upon request. The 1592U89 suppliers may include 1592U89 API manufacturers, exporters, distributors and traders.
click here to find a list of 1592U89 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 1592U89 Drug Master File in Japan (1592U89 JDMF) empowers 1592U89 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 1592U89 JDMF during the approval evaluation for pharmaceutical products. At the time of 1592U89 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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