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 Janumet manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Janumet, including repackagers and relabelers. The FDA regulates Janumet manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Janumet 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 Janumet supplier is an individual or a company that provides Janumet active pharmaceutical ingredient (API) or Janumet finished formulations upon request. The Janumet suppliers may include Janumet 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 Janumet Drug Master File in Japan (Janumet JDMF) empowers Janumet 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 Janumet JDMF during the approval evaluation for pharmaceutical products. At the time of Janumet 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 Janumet suppliers with JDMF on PharmaCompass.
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