01 2F.I.S. Fabbrica Italiana Sintetici
02 1Industriale Chimica
03 1Mallinckrodt Pharmaceuticals
04 1Olon S.p.A
01 1PENTAZOCINE
02 1PENTAZOCINE HCI
03 2PENTAZOCINE HYDROCHLORIDE
04 1PENTAZOCINE HYDROCHLORIDE USP
01 1Ireland
02 4Italy
01 3Active
02 2Inactive
01 2Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-23
Pay. Date : 2016-04-27
DMF Number : 30214
Submission : 2016-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-22
Pay. Date : 2015-02-11
DMF Number : 3776
Submission : 1980-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13983
Submission : 1999-02-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12871
Submission : 1998-02-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18345
Submission : 2005-02-11
Status : Inactive
Type : II
A Pentazocine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentazocine, including repackagers and relabelers. The FDA regulates Pentazocine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentazocine 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 Pentazocine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pentazocine supplier is an individual or a company that provides Pentazocine active pharmaceutical ingredient (API) or Pentazocine finished formulations upon request. The Pentazocine suppliers may include Pentazocine API manufacturers, exporters, distributors and traders.
click here to find a list of Pentazocine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pentazocine DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentazocine active pharmaceutical ingredient (API) in detail. Different forms of Pentazocine DMFs exist exist since differing nations have different regulations, such as Pentazocine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentazocine DMF submitted to regulatory agencies in the US is known as a USDMF. Pentazocine USDMF includes data on Pentazocine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentazocine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pentazocine suppliers with USDMF on PharmaCompass.
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