Zach System is committed to providing Highly Customized Solutions for all your Development Programs.
01 1ZACH System SA
02 1ChemWerth Inc
03 1Neuland Laboratories
04 1Akums Lifesciences
05 1Alembic Pharmaceuticals Limited
06 1Amino Chemicals
07 1Aurobindo Pharma Limited
08 1Cadila Pharmaceuticals
09 1Cipla
10 1Glenmark Life Sciences
11 1HONOUR LAB LTD
12 1Jubilant Generics
13 1MSN Laboratories
14 1Megafine Pharma (P) Limited
15 1RANBAXY LABORATORIES LIMITED
16 1Raks Pharma
17 1Sun Pharmaceutical Industries Limited
18 1Tai Heng Industry Co., Ltd
19 1Viatris
20 1Zhejiang Medicine Co Ltd
21 1Zydus Lifesciences
01 3BOSENTAN
02 14BOSENTAN MONOHYDRATE
03 2BOSENTAN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE)
04 1BOSENTAN MONOHYDRATE [ROUTE CODE - 'BN']
05 1BOSENTAN, NON-STERILE BULK DRUG SUBSTANCE
01 2China
02 1France
03 15India
04 1Malta
05 2U.S.A
01 19Active
02 2Inactive
01 12Complete
02 9Blank
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
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-09
Pay. Date : 2015-03-04
DMF Number : 29001
Submission : 2015-03-03
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 : 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
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 21 companies offering Bosentan Hydrate
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