AMI Lifesciences is Driven by Chemistry. Powered by People.
01 1Ami Lifesciences Private Limited
02 1Catalent Pharma Solutions
03 1Formosa Laboratories
04 1Grace
05 1KINGLAND CHEMICALS CO LTD
06 1Novartis Pharmaceuticals Corporation
07 1Siegfried AG
01 3BENZONATATE
02 2BENZONATATE USP
03 1TESSALON 100 MG AND 200 MG SOFTGEL CAPSULES AND BENZONATATE 100 MG AND 200 MG SOFTGEL CAPSULES
04 1TESSALON DRUG SUBSTANCE, (BENZONATATE, USP)
01 1China
02 1India
03 2Switzerland
04 1Taiwan
05 2U.S.A
01 4Active
02 3Inactive
01 3Complete
02 4Blank
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39002
Submission : 2023-12-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12327
Submission : 1997-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-03
Pay. Date : 2013-05-03
DMF Number : 21703
Submission : 2008-06-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-06
Pay. Date : 2013-05-23
DMF Number : 5196
Submission : 1983-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24194
Submission : 2010-09-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12421
Submission : 1997-03-14
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-31
Pay. Date : 2014-10-23
DMF Number : 7843
Submission : 1988-12-19
Status : Active
Type : II
A Benzonatate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzonatate, including repackagers and relabelers. The FDA regulates Benzonatate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzonatate 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 Benzonatate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benzonatate supplier is an individual or a company that provides Benzonatate active pharmaceutical ingredient (API) or Benzonatate finished formulations upon request. The Benzonatate suppliers may include Benzonatate API manufacturers, exporters, distributors and traders.
click here to find a list of Benzonatate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benzonatate DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzonatate active pharmaceutical ingredient (API) in detail. Different forms of Benzonatate DMFs exist exist since differing nations have different regulations, such as Benzonatate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzonatate DMF submitted to regulatory agencies in the US is known as a USDMF. Benzonatate USDMF includes data on Benzonatate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzonatate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benzonatate suppliers with USDMF on PharmaCompass.
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