DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories Ltd.
01 1Carfilzomib
01 1India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registration Number : 307MF10126
Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA
Initial Date of Registration : 2025-10-15
Latest Date of Registration : 2025-10-15
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A AB01565867_02 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AB01565867_02, including repackagers and relabelers. The FDA regulates AB01565867_02 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AB01565867_02 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 AB01565867_02 supplier is an individual or a company that provides AB01565867_02 active pharmaceutical ingredient (API) or AB01565867_02 finished formulations upon request. The AB01565867_02 suppliers may include AB01565867_02 API manufacturers, exporters, distributors and traders.
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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 AB01565867_02 Drug Master File in Japan (AB01565867_02 JDMF) empowers AB01565867_02 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 AB01565867_02 JDMF during the approval evaluation for pharmaceutical products. At the time of AB01565867_02 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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