01 1Honor Lab Limited
01 1Alogliptin benzoate “D”
01 1India
Registration Number : 306MF10015
Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.
Initial Date of Registration : 2024-01-24
Latest Date of Registration : 2024-01-24
A Alogliptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alogliptin, including repackagers and relabelers. The FDA regulates Alogliptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alogliptin 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 Alogliptin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alogliptin supplier is an individual or a company that provides Alogliptin active pharmaceutical ingredient (API) or Alogliptin finished formulations upon request. The Alogliptin suppliers may include Alogliptin API manufacturers, exporters, distributors and traders.
click here to find a list of Alogliptin 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 Alogliptin Drug Master File in Japan (Alogliptin JDMF) empowers Alogliptin 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 Alogliptin JDMF during the approval evaluation for pharmaceutical products. At the time of Alogliptin 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 Alogliptin suppliers with JDMF on PharmaCompass.
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