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List of Drug Master Files (KDMF) for Budesonide Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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$ API Ref.Price (USD/KG) : 3,449Xls
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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 1Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

07 1AVIK Pharmaceutical. Ltd

08 2AstraZeneca AB @Aspen Oss BV

09 1AstraZeneca AB @Minakem Dunkerque production@Minakem Dunkerque production

10 1Newchem SpA@MICROCHEM Srl

11 1Sicor Societa' Italiana Corticosteroidi SRL@Micro-Macinazione SA

12 1Sterling SpA@Microchem Srl

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

Undifferentiated budesonide

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

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02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAxplora- The partner of choice for complex APIs.

Budesonide

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...

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