Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
01 1Honor Lab Limited
01 1Alogliptin benzoate “D”
01 1India
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
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
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A OSENI manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of OSENI, including repackagers and relabelers. The FDA regulates OSENI manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. OSENI 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 OSENI manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A OSENI supplier is an individual or a company that provides OSENI active pharmaceutical ingredient (API) or OSENI finished formulations upon request. The OSENI suppliers may include OSENI API manufacturers, exporters, distributors and traders.
click here to find a list of OSENI 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 OSENI Drug Master File in Japan (OSENI JDMF) empowers OSENI 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 OSENI JDMF during the approval evaluation for pharmaceutical products. At the time of OSENI 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 OSENI suppliers with JDMF on PharmaCompass.
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