Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 2Minakem Dunkerque production
02 2Minakem Dunkerque production@AstraZeneca AB
03 1Farmabios SpA@Microchem Srl
04 1Aspen Oss BV
05 1Aspen Oss BV@AstraZeneca AB
06 1AVIK Pharmaceutical. Ltd
07 2AstraZeneca AB @Aspen Oss BV
08 1AstraZeneca AB @Minakem Dunkerque production@Minakem Dunkerque production
09 1Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
10 1Newchem SpA@MICROCHEM Srl
11 1Sicor Societa' Italiana Corticosteroidi SRL@Micro-Macinazione SA
12 1Sterling SpA@Microchem Srl
01 7AstraZeneca Korea Ltd.
02 1Daewoong Pharmaceutical Co., Ltd.
03 1Hiple Co., Ltd.
04 3Samoh Pharmaceutical Co., Ltd.
05 1Sungjin Exim Co., Ltd.
06 1Synex Co., Ltd.
07 1YuYu Pharmaceutical Co., Ltd.
01 3Budesonide
02 12Undifferentiated budesonide
01 1China
02 4France
03 1Germany
04 1India
05 3Italy
06 2Netherlands
07 3United Kingdom
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Registrant Name : Daewoong Pharmaceutical Co., Ltd.
Registration Date : 2023-07-19
Registration Number : 20221124-209-J-1409(A)
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640, France
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-06-01
Registration Number : 20200601-209-J-448
Manufacturer Name : Farmabios SpA@Microchem Srl
Manufacturer Address : 27027, via Pavia 1, GROPELLO CAIROLI-(PV), Italy@Via Turati, 2-29017 Fiorenzuola D'ar...
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2022-11-24
Registration Number : 20221124-209-J-1410
Manufacturer Name : Aspen Oss BV@AstraZeneca AB
Manufacturer Address : Veersemeer 4, Oss, 5347 JN, The Netherlands@Forskargatan 18, Sodertalje, 151 36, Swed...
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2021-07-21
Registration Number : 20210721-209-J-1057
Manufacturer Name : Minakem Dunkerque production...
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht 59640 Dunkerque, France@F...
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2022-11-24
Registration Number : 20221124-209-J-1409
Manufacturer Name : Minakem Dunkerque production
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht 59640 Dunkerque, France
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2022-11-24
Registration Number : 20221124-209-J-1412
Manufacturer Name : Minakem Dunkerque production...
Manufacturer Address : 224 avenue de la Dordogne Zone d'entreprises du Nord Gracht Dunkerque, 59640, France@...
Registrant Name : Synex Co., Ltd.
Registration Date : 2021-07-22
Registration Number : 20210722-209-J-1071
Manufacturer Name : Aspen Oss BV
Manufacturer Address : Veersemeer 4, Oss, 5347 JN, The Netherlands
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2022-03-15
Registration Number : 20220315-209-J-1249
Manufacturer Name : Newchem SpA@MICROCHEM Srl
Manufacturer Address : Via Roveggia, 47-37136 Verona (VR), Italy@Via Turati, 2 – 29017 Fiorenzuola d'Arda ...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-06-07
Registration Number : 20220607-209-J-1264
Manufacturer Name : Sicor Societa' Italiana Cort...
Manufacturer Address : Tenuta S. Alessandro 13048 Santhia (VC), Italy@Zona Artigianale 11 6995-Madonna del p...
Registrant Name : YuYu Pharmaceutical Co., Ltd.
Registration Date : 2022-08-09
Registration Number : 20220809-209-J-1324
Manufacturer Name : Sterling SpA@Microchem Srl
Manufacturer Address : Via della Carboneria 30(loc. Solomeo)-06073 Corciano Perugia, Italy@Via Turati, 2-290...
A Pulmicort manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pulmicort, including repackagers and relabelers. The FDA regulates Pulmicort manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pulmicort 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 Pulmicort manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pulmicort supplier is an individual or a company that provides Pulmicort active pharmaceutical ingredient (API) or Pulmicort finished formulations upon request. The Pulmicort suppliers may include Pulmicort API manufacturers, exporters, distributors and traders.
click here to find a list of Pulmicort 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 Pulmicort Drug Master File in Korea (Pulmicort KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pulmicort. The MFDS reviews the Pulmicort KDMF as part of the drug registration process and uses the information provided in the Pulmicort KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pulmicort 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 Pulmicort API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pulmicort suppliers with KDMF on PharmaCompass.
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