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
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 :
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 :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-13
Pay. Date : 2015-07-09
DMF Number : 26038
Submission : 2012-05-09
Status :
Type : II
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.
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.
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.
We have 21 companies offering Bosentan
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