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

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Kookjeon Pharmaceutical Co., Ltd.
2012-12-05
Number 342-9-ND
ALEMBIC PHARMACEUTICALS L...
India
Plot No. 842-843, Village...
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Dongbang FTL Co., Ltd.
2010-12-30
510-5-ND
Dongbang FTL Co., Ltd.
South Korea
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Hanseochem Co., Ltd.
2013-09-05
787-3-ND
Hanseochem Co., Ltd.
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Korea Janssen Co., Ltd.
2011-12-15
4722-3-ND
HAS Healthcare Advanced S...
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Jeil Pharmaceutical Co., Ltd.
2013-02-06
21-10-ND
Jeil Pharmaceutical Co., ...
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Kyungbo Pharmaceutical Co., Ltd.
2014-03-18
1673-12-ND
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174, Silok-ro, Asan-si, C...
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  • TABLET;ORAL - 125MG
  • TABLET;ORAL - 62.5MG

Looking for 147536-97-8 / Bosentan Hydrate API manufacturers, exporters & distributors?

Bosentan Hydrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Bosentan Hydrate 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 Bosentan Hydrate manufacturer or Bosentan Hydrate supplier for your needs.

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

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

API | Excipient name

Bosentan Hydrate

Synonyms

147536-97-8, Tracleer, Actelion, Bosentan anhydrous, Ro 47-0203, Ro-47-0203

Cas Number

147536-97-8

Unique Ingredient Identifier (UNII)

XUL93R30K2

About Bosentan Hydrate

A sulfonamide and pyrimidine derivative that acts as a dual endothelin receptor antagonist used to manage PULMONARY HYPERTENSION and SYSTEMIC SCLEROSIS.

Bosentan Monohydrate Manufacturers

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

Bosentan Monohydrate Suppliers

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

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

Bosentan Monohydrate KDMF

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

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

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

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

Bosentan Monohydrate Manufacturers | Traders | Suppliers

Bosentan Monohydrate Manufacturers, Traders, Suppliers 1
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We have 6 companies offering Bosentan Monohydrate

Get in contact with the supplier of your choice:

  1. Alembic Pharmaceuticals Limited
  2. Dongbang FTL
  3. Hanseo Chem
  4. Helsinn Advanced Synthesis
  5. Jeil Pharmaceutical Co., Ltd
  6. Kyongbo Pharmaceutical Co., Ltd
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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