With Fermion, start the journey of your innovative API.
01 1Fermion Oy
02 1Inistesti Co., Ltd.
03 1MSN Laboratories Private Limited
01 1Inistesti Co., Ltd.
02 1Kukjeon Pharmaceutical Co., Ltd.
03 1Masung LS Co., Ltd.
01 2Nintedanib esilate
02 1Nintedanib esilate hemihydrate
01 1Finland
02 1India
03 1South Korea
Nintedanib esilate hemihydrate
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2022-01-12
Registration Number : 163-23-ND
Manufacturer Name : Fermion Oy
Manufacturer Address : Lääketehtaantie 2, Oulu, FI-90660, Finland
Registrant Name : Inistesti Co., Ltd.
Registration Date : 2023-07-10
Registration Number : 2220-16-ND
Manufacturer Name : Inistesti Co., Ltd.
Manufacturer Address : 500 Shinnae-ro, Geumwang-eup, Eumseong-gun, Chungcheongbuk-do
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-01-13
Registration Number : Number 173-33-ND
Manufacturer Name : MSN Laboratories Private Lim...
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), S...
A Nintedanib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nintedanib, including repackagers and relabelers. The FDA regulates Nintedanib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nintedanib 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 Nintedanib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nintedanib supplier is an individual or a company that provides Nintedanib active pharmaceutical ingredient (API) or Nintedanib finished formulations upon request. The Nintedanib suppliers may include Nintedanib API manufacturers, exporters, distributors and traders.
click here to find a list of Nintedanib 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 Nintedanib Drug Master File in Korea (Nintedanib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nintedanib. The MFDS reviews the Nintedanib KDMF as part of the drug registration process and uses the information provided in the Nintedanib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nintedanib 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 Nintedanib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nintedanib suppliers with KDMF on PharmaCompass.
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