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List of Drug Master Files (DMF) of Bosentan Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 ZACH System SA (1)

02 ChemWerth Inc (1)

03 Neuland Laboratories (1)

04 Megafine Pharma (P) Limited (1)

05 Akums Lifesciences (1)

06 Alembic Pharmaceuticals Limited (1)

07 Amino Chemicals (1)

08 Aurobindo Pharma Limited (1)

09 Cadila Pharmaceuticals (1)

10 Cipla (1)

11 Glenmark Life Sciences (1)

12 HONOUR LAB LTD (1)

13 Jubilant Generics (1)

14 MSN Laboratories (1)

15 RANBAXY LABORATORIES LIMITED (1)

16 Raks Pharma (1)

17 Sun Pharmaceutical Industries Limited (1)

18 Tai Heng Industry Co., Ltd (1)

19 Viatris (1)

20 Zhejiang Medicine Co Ltd (1)

21 Zydus Lifesciences (1)

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01 BOSENTAN (3)

02 BOSENTAN MONOHYDRATE (14)

03 BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) (2)

04 BOSENTAN MONOHYDRATE [ROUTE CODE - 'BN'] (1)

05 BOSENTAN, NON-STERILE BULK DRUG SUBSTANCE (1)

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01 China (2)

02 France (1)

03 India (15)

04 Malta (1)

05 U.S.A (2)

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01 Active (19)

02 Inactive (2)

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01 Complete (12)

02 Blank (9)

26038
Active
2012-05-09
Complete
2015-10-13
2015-07-09
II
URL Supplier Web Content
25099
Active
2011-06-30
Complete
2017-10-27
2017-10-06
II
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URL Supplier Web Content
23455
Active
2010-01-14
N/A
II
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URL Supplier Web Content
24124
Active
2010-09-09
N/A
II
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URL Supplier Web Content
23255
Active
2009-11-11
Complete
2013-11-19
2013-09-20
II
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URL Supplier Web Content
23354
Active
2009-12-04
Complete
2013-01-24
2012-11-06
II
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URL Supplier Web Content
25915
Active
2012-04-02
Complete
2014-05-28
2014-04-04
II
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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 Manufacturers

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

Bosentan Suppliers

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

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

Bosentan USDMF

A Bosentan DMF (Drug Master File) is a document detailing the whole manufacturing process of Bosentan active pharmaceutical ingredient (API) in detail. Different forms of Bosentan DMFs exist exist since differing nations have different regulations, such as Bosentan USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Bosentan DMF submitted to regulatory agencies in the US is known as a USDMF. Bosentan USDMF includes data on Bosentan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bosentan USDMF is kept confidential to protect the manufacturer’s intellectual property.

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

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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