Coral Budesonide Coral Budesonide

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List of Korea Drug Master Files (KDMF) for Budesonide Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Flag France
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Daewoong Pharmaceutical Co., Ltd.
2023-07-19
20221124-209-J-1409(A)
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
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AstraZeneca Korea Co., Ltd.
2021-07-21
20210721-209-J-1057
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
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Digital Content Digital Content
AstraZeneca Korea Co., Ltd.
2022-11-24
20221124-209-J-1412
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
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Digital Content Digital Content
AstraZeneca Korea Co., Ltd.
2022-11-24
20221124-209-J-1409
Minakem Dunkerque product...
France
224 avenue de la Dordogne...
Flag Netherlands
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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...
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Digital Content Digital Content
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...
Flag Germany
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Samo Pharmaceutical Co., Ltd.
2020-06-01
20200601-209-J-448
Farmabios SpA@Microchem S...
Germany
27027, via Pavia 1, GROPE...
Axplora CB

2024 ACI Convention

Not Confirmed

envelop Contact Supplier
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Samo Pharmaceutical Co., Ltd.
2021-03-29
20210329-209-J-903
Hubei Gedian Humanwell Ph...
China
Gedian Economic Developme...
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AstraZeneca Korea Co., Ltd.
2021-10-25
20211025-209-J-1130
AstraZeneca AB @Minakem D...
United Kingdom
Forskargatan 18, Sodertal...
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AstraZeneca Korea Co., Ltd.
2021-10-25
20211025-209-J-1129
AstraZeneca AB @Aspen Oss...
United Kingdom
Forskargatan 18, Sodertal...
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AstraZeneca Korea Co., Ltd.
2021-08-28
20210828-209-J-1099
AstraZeneca AB @Aspen Oss...
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Forskargatan 18, Sodertal...
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Hiple Co., Ltd.
2020-08-13
20200813-209-J-486
AVIK Pharmaceutical. Ltd
India
A-1/7, 1St Phaes, GIDC, C...
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Sungjin Exim Co., Ltd.
2022-03-15
20220315-209-J-1249
Newchem SpA@MICROCHEM Srl
Italy
Via Roveggia, 47-37136 Ve...
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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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  • SPRAY, METERED;NASAL - 0.032MG/SPRAY
  • SUSPENSION;INHALATION - 0.25MG/2ML
  • SUSPENSION;INHALATION - 0.5MG/2ML
  • SUSPENSION;INHALATION - 1MG/2ML
  • CAPSULE, DELAYED RELEASE;ORAL - 6MG
  • CAPSULE, DELAYED RELEASE;ORAL - 9MG
  • CAPSULE, DELAYED RELEASE;ORAL - 3MG
  • AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH
  • AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH

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 Manufacturers

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

Budesonide Suppliers

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

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

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

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

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

Budesonide Manufacturers | Traders | Suppliers

Budesonide Manufacturers, Traders, Suppliers 1
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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