01 1Cipla
02 1Fuxin Long Rui Pharmaceutical
03 1Glenmark Life Sciences
04 1Hetero Drugs
05 1MSN Laboratories
01 5DACLATASVIR DIHYDROCHLORIDE
01 1China
02 4India
01 4Active
02 1Inactive
01 1Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30737
Submission : 2016-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33381
Submission : 2018-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32471
Submission : 2018-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-07
Pay. Date : 2016-09-28
DMF Number : 30975
Submission : 2016-10-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33496
Submission : 2018-12-31
Status : Active
Type : II
A Daclatasvir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daclatasvir, including repackagers and relabelers. The FDA regulates Daclatasvir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daclatasvir 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 Daclatasvir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Daclatasvir supplier is an individual or a company that provides Daclatasvir active pharmaceutical ingredient (API) or Daclatasvir finished formulations upon request. The Daclatasvir suppliers may include Daclatasvir API manufacturers, exporters, distributors and traders.
click here to find a list of Daclatasvir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Daclatasvir DMF (Drug Master File) is a document detailing the whole manufacturing process of Daclatasvir active pharmaceutical ingredient (API) in detail. Different forms of Daclatasvir DMFs exist exist since differing nations have different regulations, such as Daclatasvir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Daclatasvir DMF submitted to regulatory agencies in the US is known as a USDMF. Daclatasvir USDMF includes data on Daclatasvir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Daclatasvir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Daclatasvir suppliers with USDMF on PharmaCompass.
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