TAPI offers customized CDMO Solutions for API development and manufacturing services.
01 1TAPI Technology & API Services
02 1Amino Chemicals
03 1Apotex Pharmachem
04 1Aurobindo Pharma Limited
05 1Centaur Pharmaceuticals
06 1Cipla
07 1Gador SA
08 1Orchid Pharma
09 1Zydus Lifesciences
01 7ZALEPLON
02 2ZALEPLON USP
01 1Argentina
02 1Canada
03 5India
04 1Israel
05 1Malta
01 4Active
02 5Inactive
01 1Complete
02 8Blank
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
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DMF Number : 17565
Submission : 2004-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 16785
Submission : 2003-08-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 22572
Submission : 2009-02-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19398
Submission : 2006-04-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-02
Pay. Date : 2013-09-25
DMF Number : 27568
Submission : 2013-09-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18022
Submission : 2005-01-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19015
Submission : 2005-12-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20877
Submission : 2007-09-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21482
Submission : 2008-04-01
Status : Inactive
Type : II
A Zaleplon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zaleplon, including repackagers and relabelers. The FDA regulates Zaleplon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zaleplon 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 Zaleplon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zaleplon supplier is an individual or a company that provides Zaleplon active pharmaceutical ingredient (API) or Zaleplon finished formulations upon request. The Zaleplon suppliers may include Zaleplon API manufacturers, exporters, distributors and traders.
click here to find a list of Zaleplon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zaleplon DMF (Drug Master File) is a document detailing the whole manufacturing process of Zaleplon active pharmaceutical ingredient (API) in detail. Different forms of Zaleplon DMFs exist exist since differing nations have different regulations, such as Zaleplon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zaleplon DMF submitted to regulatory agencies in the US is known as a USDMF. Zaleplon USDMF includes data on Zaleplon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zaleplon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zaleplon suppliers with USDMF on PharmaCompass.
We have 9 companies offering Zaleplon
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