ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Boehringer Ingelheim GmbH
03 1Icrom
04 1Sun Pharmaceutical Industries Limited
05 1Trifarma
06 1Wuhan Calmland Pharmaceuticals
01 1EPINASTINE HCL
02 5EPINASTINE HYDROCHLORIDE
01 1China
02 1Germany
03 1India
04 2Italy
05 1U.S.A
01 6Active
01 1Complete
02 5Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21974
Submission : 2008-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15003
Submission : 2000-09-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-27
Pay. Date : 2020-05-19
DMF Number : 21830
Submission : 2008-07-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22854
Submission : 2009-06-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21851
Submission : 2008-08-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40256
Submission : 2024-08-07
Status : Active
Type : II
A Epinastine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epinastine, including repackagers and relabelers. The FDA regulates Epinastine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epinastine 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 Epinastine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epinastine supplier is an individual or a company that provides Epinastine active pharmaceutical ingredient (API) or Epinastine finished formulations upon request. The Epinastine suppliers may include Epinastine API manufacturers, exporters, distributors and traders.
click here to find a list of Epinastine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Epinastine DMF (Drug Master File) is a document detailing the whole manufacturing process of Epinastine active pharmaceutical ingredient (API) in detail. Different forms of Epinastine DMFs exist exist since differing nations have different regulations, such as Epinastine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Epinastine DMF submitted to regulatory agencies in the US is known as a USDMF. Epinastine USDMF includes data on Epinastine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Epinastine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Epinastine suppliers with USDMF on PharmaCompass.
We have 6 companies offering Epinastine
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