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01 1ZACH System SA
02 1Neuland Laboratories
03 1Akums Lifesciences
04 1Alembic Pharmaceuticals Limited
05 1Amino Chemicals
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08 1Cipla
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11 1Jubilant Generics
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01 3BOSENTAN
02 14BOSENTAN MONOHYDRATE
03 2BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE)
04 1BOSENTAN MONOHYDRATE [ROUTE CODE - 'BN']
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01 2China
02 1France
03 15India
04 1Malta
05 1U.S.A
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01 18Active
02 2Inactive
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Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-25
Pay. Date : 2014-01-31
DMF Number : 24929
Submission : 2011-05-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-13
Pay. Date : 2015-07-09
DMF Number : 26038
Submission : 2012-05-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26158
Submission : 2012-05-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-10-06
DMF Number : 25099
Submission : 2011-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23455
Submission : 2010-01-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24124
Submission : 2010-09-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2013-09-26
DMF Number : 25354
Submission : 2011-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-19
Pay. Date : 2013-09-20
DMF Number : 23255
Submission : 2009-11-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-24
Pay. Date : 2012-11-06
DMF Number : 23354
Submission : 2009-12-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-28
Pay. Date : 2014-04-04
DMF Number : 25915
Submission : 2012-04-02
Status : Active
Type : II
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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.
A Bosentan Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bosentan Hydrate, including repackagers and relabelers. The FDA regulates Bosentan Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bosentan Hydrate 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 Hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bosentan Hydrate supplier is an individual or a company that provides Bosentan Hydrate active pharmaceutical ingredient (API) or Bosentan Hydrate finished formulations upon request. The Bosentan Hydrate suppliers may include Bosentan Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Bosentan Hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bosentan Hydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Bosentan Hydrate active pharmaceutical ingredient (API) in detail. Different forms of Bosentan Hydrate DMFs exist exist since differing nations have different regulations, such as Bosentan Hydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bosentan Hydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Bosentan Hydrate USDMF includes data on Bosentan Hydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bosentan Hydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bosentan Hydrate suppliers with USDMF on PharmaCompass.
We have 19 companies offering Bosentan Hydrate
Get in contact with the supplier of your choice: