01 1Glenmark Life Sciences LTD.
02 3Glenmark Life Sciences Limited
03 2Hetero Drugs Limited
04 1MSD International GmbH (Puerto Rico Branch) LLC.
05 1Optimus Drugs Private Limited
06 1Siegfried Evionnaz SA
01 1Ace Pharma Co., Ltd.
02 1Aging Life Science Co., Ltd.
03 1Daewoong Bio Co., Ltd.
04 1Hwail Pharmaceutical Co., Ltd.
05 2Korea MSD Co., Ltd.
06 2M-Peak Korea Co., Ltd.
07 1Wonpung Pharmaceutical Co., Ltd.
01 9Aprepitant
01 7India
02 1Switzerland
03 1U.S.A
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2015-12-23
Registration Number : No. 6580-19-ND
Manufacturer Name : Glenmark Life Sciences Limit...
Manufacturer Address : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar, City : Ankleshwar - 393 002, Dist...
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2019-07-18
Registration Number : No. 6580-19-ND(3)
Manufacturer Name : Glenmark Life Sciences LTD.
Manufacturer Address : Plot No 3109, GIDC Industrial Estate, Ankleshwar City: Ankleshwar-393 002, Dist: Bhar...
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2017-12-08
Registration Number : No. 6580-19-ND(1)
Manufacturer Name : Glenmark Life Sciences Limit...
Manufacturer Address : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar, City : Ankleshwar - 393 002, Dist...
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2018-11-09
Registration Number : No. 6580-19-ND(2)
Manufacturer Name : Glenmark Life Sciences Limit...
Manufacturer Address : Plot No. 3109, GIDC, Industrial Estate, Ankleshwar, City : Ankleshwar - 393 002, Dist...
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2016-06-17
Registration Number : No. 3838-1-ND(1)
Manufacturer Name : Hetero Drugs Limited
Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...
Registrant Name : Wonpung Pharmaceutical Co., Ltd.
Registration Date : 2012-04-27
Registration Number : No. 3838-1-ND
Manufacturer Name : Hetero Drugs Limited
Manufacturer Address : Sy.No.213,214&255, Bonthapally Village, Gummadidala Mandal, Sangareddy District, Tela...
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2005-07-28
Registration Number : No. 906-4-ND
Manufacturer Name : MSD International GmbH (Puer...
Manufacturer Address : Road #2, Kilometer 56.7, Barceloneta, PR 00617
Registrant Name : Ace Pharma Co., Ltd.
Registration Date : 2020-11-19
Registration Number : Su105-1-ND
Manufacturer Name : Optimus Drugs Private Limite...
Manufacturer Address : Sy. No. 239 & 240, Dothigudem Village, Pochampally Mandal, Yadadri-Bhuvanagiri Distri...
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2016-01-14
Registration Number : Su3281-16-ND
Manufacturer Name : Siegfried Evionnaz SA
Manufacturer Address : Route du Simplon 1, 36, 1902, Evionnaz, Switzerland_x000D_
A Aprepitant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aprepitant, including repackagers and relabelers. The FDA regulates Aprepitant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aprepitant 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 Aprepitant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aprepitant supplier is an individual or a company that provides Aprepitant active pharmaceutical ingredient (API) or Aprepitant finished formulations upon request. The Aprepitant suppliers may include Aprepitant API manufacturers, exporters, distributors and traders.
click here to find a list of Aprepitant 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 Aprepitant Drug Master File in Korea (Aprepitant KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aprepitant. The MFDS reviews the Aprepitant KDMF as part of the drug registration process and uses the information provided in the Aprepitant KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aprepitant 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 Aprepitant API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Aprepitant suppliers with KDMF on PharmaCompass.
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