01 1Dongbang FTL Co., Ltd.
02 2Jeil Pharmaceutical Co., Ltd.
03 1MSD International GmbH (Puerto Rico Branch) LLC.
04 1Tianish Laboratories Limited (Unit-1)
05 1[Partial process consignment manufacturing (manufacturing requester)] (Small batch manufacturing) Dasan Pharmaceutical Co., Ltd. @ Myeongmoon Bio Co., Ltd. @ [Starting material manufacturing plant] Hebei Baiqi Pharmaceutical Co., Ltd.
01 1Ace Biopharm Co., Ltd.
02 1Dasan Pharmaceutical Co., Ltd.
03 1Dongbang FTL Co., Ltd.
04 2Jeil Pharmaceutical Co., Ltd.
05 1Korea MSD Co., Ltd.
01 1Sitagliptin camsylate
02 5Sitagliptin phosphate
01 1India
02 4South Korea
03 1U.S.A
Registrant Name : Dasan Pharmaceutical Co., Ltd.
Registration Date : 2015-03-03
Registration Number : Su2243-8-ND
Manufacturer Name : [Partial process consignment...
Manufacturer Address : [Partial process consignment manufacturing (manufacturing requester)] (Small batch ma...
Registrant Name : Dongbang FTL Co., Ltd.
Registration Date : 2020-07-14
Registration Number : 1731-18-ND
Manufacturer Name : Dongbang FTL Co., Ltd.
Manufacturer Address : 78, Yakjakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2018-08-27
Registration Number : 1668-22-ND
Manufacturer Name : Jeil Pharmaceutical Co., Ltd...
Manufacturer Address : 7, Cheonggang-ga-chang-ro, Baekam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do (B-dong an...
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2017-06-27
Registration Number : 1668-20-ND
Manufacturer Name : Jeil Pharmaceutical Co., Ltd...
Manufacturer Address : 7, Cheonggang-ga-chang-ro, Baekam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do (B-dong an...
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2007-08-31
Registration Number : 906-3-ND
Manufacturer Name : MSD International GmbH (Puer...
Manufacturer Address : Road #2, Kilometer 56.7, Barceloneta, PR 00617
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2015-01-06
Registration Number : Su5217-4-ND
Manufacturer Name : Tianish Laboratories Limited...
Manufacturer Address : Sy.No.10, Gaddapotharam(V), Industrial Area, Khazipali, Medak District, Andhra Prades...
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.
click here to find a list of Janumet manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
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.
click here to find a list of Janumet suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Janumet Drug Master File in Korea (Janumet KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Janumet. The MFDS reviews the Janumet KDMF as part of the drug registration process and uses the information provided in the Janumet KDMF to evaluate the safety and efficacy of the drug.
After submitting a Janumet KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Janumet API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Janumet suppliers with KDMF on PharmaCompass.
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