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List of Drug Master Files (KDMF) for Budesonide 21-acetate Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Minakem Dunkerque production (2)

02 Minakem Dunkerque production@AstraZeneca AB (2)

03 Farmabios SpA@Microchem Srl (1)

04 Aspen Oss B.V. (1)

05 Aspen Oss BV@AstraZeneca AB (1)

06 Hubei Gedian Humanwell Pharmaceutical Co., Ltd. (1)

07 AVIK Pharmaceutical. Ltd (1)

08 AstraZeneca AB @Aspen Oss BV (2)

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

10 Newchem SpA@MICROCHEM Srl (1)

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

12 Sterling SpA@Microchem Srl (1)

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01 AstraZeneca Korea Co., Ltd. (7)

02 Daewoong Pharmaceutical Co., Ltd. (1)

03 Hiple Co., Ltd. (1)

04 Samo Pharmaceutical Co., Ltd. (3)

05 Sinex Co., Ltd. (1)

06 Sungjin Exim Co., Ltd. (1)

07 Yuyu Pharmaceutical Co., Ltd. (1)

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01 Micronized budesonide (12)

02 budesonide (3)

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01 China (1)

02 France (4)

03 Germany (1)

04 India (1)

05 Italy (3)

06 Netherlands (2)

07 United Kingdom (3)

Daewoong Pharmaceutical Co., Ltd.
2023-07-19
20221124-209-J-1409(A)
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
Samo Pharmaceutical Co., Ltd.
2020-06-01
20200601-209-J-448
Farmabios SpA@Microchem S...
Germany
27027, via Pavia 1, GROPE...
Axplora CB

EMWA 2024

Not Confirmed

envelop Contact Supplier
NA Not Available For Sales
AstraZeneca Korea Co., Ltd.
2022-11-24
20221124-209-J-1410
Aspen Oss BV@AstraZeneca ...
Netherlands
Veersemeer 4, Oss, 5347 J...
Samo Pharmaceutical Co., Ltd.
2021-03-29
20210329-209-J-903
Hubei Gedian Humanwell Ph...
China
Gedian Economic Developme...
AstraZeneca Korea Co., Ltd.
2021-07-21
20210721-209-J-1057
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
AstraZeneca Korea Co., Ltd.
2022-11-24
20221124-209-J-1412
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
AstraZeneca Korea Co., Ltd.
2022-11-24
20221124-209-J-1409
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
NA Not Available For Sales
Sinex Co., Ltd.
2021-07-22
20210722-209-J-1071
Aspen Oss B.V.
Netherlands
Veersemeer 4, Oss, 5347 J...
URL Supplier Web Content
Samo Pharmaceutical Co., Ltd.
2022-06-07
20220607-209-J-1264
Sicor Societa' Italiana C...
Italy
Tenuta S. Alessandro 1304...
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Yuyu Pharmaceutical Co., Ltd.
2022-08-09
20220809-209-J-1324
Sterling SpA@Microchem Sr...
Italy
Via della Carboneria 30(l...
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Looking for 51333-22-3 / Budesonide API manufacturers, exporters & distributors?

Budesonide manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Budesonide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Budesonide manufacturer or Budesonide supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Budesonide manufacturer or Budesonide supplier.

PharmaCompass also assists you with knowing the Budesonide API Price utilized in the formulation of products. Budesonide API Price is not always fixed or binding as the Budesonide Price is obtained through a variety of data sources. The Budesonide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Budesonide

Synonyms

Pulmicort, Entocort, Rhinocort, 51333-22-3, Preferid, Rhinocort aqua

Cas Number

51333-22-3

Unique Ingredient Identifier (UNII)

Q3OKS62Q6X

About Budesonide

A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.

Budesonide 21-acetate Manufacturers

A Budesonide 21-acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Budesonide 21-acetate, including repackagers and relabelers. The FDA regulates Budesonide 21-acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Budesonide 21-acetate 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 Budesonide 21-acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Budesonide 21-acetate Suppliers

A Budesonide 21-acetate supplier is an individual or a company that provides Budesonide 21-acetate active pharmaceutical ingredient (API) or Budesonide 21-acetate finished formulations upon request. The Budesonide 21-acetate suppliers may include Budesonide 21-acetate API manufacturers, exporters, distributors and traders.

click here to find a list of Budesonide 21-acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Budesonide 21-acetate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Budesonide 21-acetate Drug Master File in Korea (Budesonide 21-acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Budesonide 21-acetate. The MFDS reviews the Budesonide 21-acetate KDMF as part of the drug registration process and uses the information provided in the Budesonide 21-acetate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Budesonide 21-acetate 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 Budesonide 21-acetate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Budesonide 21-acetate suppliers with KDMF on PharmaCompass.

Budesonide 21-acetate Manufacturers | Traders | Suppliers

Budesonide 21-acetate Manufacturers, Traders, Suppliers 1
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We have 9 companies offering Budesonide 21-acetate

Get in contact with the supplier of your choice:

  1. Axplora
  2. Minakem
  3. Aspen API
  4. Hubei Gedian Humanwell Pharmaceutical
  5. AstraZeneca
  6. Avik Pharmaceutical Limited
  7. NEWCHEM SPA
  8. Sicor Societa Italiana Corticosteroidi Srl
  9. Sterling Spa
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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