01 1Cheer Fine Pharmaceutical Co. , Ltd.
02 2F. I. S. Fabrica Italiana Sintetici S. p. A.
03 1Honor Lab Limited
04 2MSD International GmbH (Singapore Branch) (50 Tuas)
01 2Sitagliptin Phosphate
02 2Sitagliptin phosphate hydrate
03 2Sitagliptin phosphate hydrate (contains propyl gallate)
01 1China
02 1India
03 2Italy
04 2Singapore
Registration Number : 306MF10105
Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province...
Initial Date of Registration : 2024-07-24
Latest Date of Registration : 2024-07-24
Registration Number : 226MF10001
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2014-01-08
Latest Date of Registration : 2014-01-08
Sitagliptin phosphate hydrate (containing propyl gallate)
Registration Number : 305MF10116
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2023-10-12
Latest Date of Registration : 2023-10-12
Registration Number : 303MF10124
Registrant's Address : H. No. &8-3-166/7/1, Erragadda, Hyderabad-500018, Telangana, INDIA.
Initial Date of Registration : 2021-08-16
Latest Date of Registration : 2021-08-16
Sitagliptin phosphate hydrate (containing propyl gallate)
Registration Number : 305MF10105
Registrant's Address : 50 Tuas West Drive Singapore 638408
Initial Date of Registration : 2023-08-30
Latest Date of Registration : 2023-08-30
Registration Number : 231MF10016
Registrant's Address : 50 Tuas West Drive Singapore 638408
Initial Date of Registration : 2019-01-23
Latest Date of Registration : 2019-01-23
A Sitagliptin Phosphate Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sitagliptin Phosphate Monohydrate, including repackagers and relabelers. The FDA regulates Sitagliptin Phosphate Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sitagliptin Phosphate Monohydrate 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 Sitagliptin Phosphate Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sitagliptin Phosphate Monohydrate supplier is an individual or a company that provides Sitagliptin Phosphate Monohydrate active pharmaceutical ingredient (API) or Sitagliptin Phosphate Monohydrate finished formulations upon request. The Sitagliptin Phosphate Monohydrate suppliers may include Sitagliptin Phosphate Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sitagliptin Phosphate Monohydrate 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 Sitagliptin Phosphate Monohydrate Drug Master File in Japan (Sitagliptin Phosphate Monohydrate JDMF) empowers Sitagliptin Phosphate Monohydrate 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 Sitagliptin Phosphate Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Sitagliptin Phosphate Monohydrate 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 Sitagliptin Phosphate Monohydrate suppliers with JDMF on PharmaCompass.
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