Nortec Quimica is the largest API manufacturer in Latin America.
01 1Nortec Quimica
02 1Cambrex Corporation
03 1Dishman Carbogen Amcis
04 1Jiangsu Hengrui Medicine
05 1MSN Laboratories
06 1Siegfried AG
01 3BUPIVACAINE
02 3BUPIVACAINE BASE
01 1Brazil
02 1China
03 2India
04 1Switzerland
05 1U.S.A
01 6Active
01 5Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-25
Pay. Date : 2018-11-13
DMF Number : 33285
Submission : 2018-11-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-05
Pay. Date : 2015-09-29
DMF Number : 19177
Submission : 2006-02-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-13
Pay. Date : 2018-03-09
DMF Number : 32369
Submission : 2017-12-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-06
Pay. Date : 2020-06-19
DMF Number : 34900
Submission : 2020-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35322
Submission : 2020-10-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-31
Pay. Date : 2014-10-23
DMF Number : 11938
Submission : 1996-04-18
Status : Active
Type : II
A Bupivacaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bupivacaine, including repackagers and relabelers. The FDA regulates Bupivacaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bupivacaine 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 Bupivacaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bupivacaine supplier is an individual or a company that provides Bupivacaine active pharmaceutical ingredient (API) or Bupivacaine finished formulations upon request. The Bupivacaine suppliers may include Bupivacaine API manufacturers, exporters, distributors and traders.
click here to find a list of Bupivacaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bupivacaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Bupivacaine active pharmaceutical ingredient (API) in detail. Different forms of Bupivacaine DMFs exist exist since differing nations have different regulations, such as Bupivacaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bupivacaine DMF submitted to regulatory agencies in the US is known as a USDMF. Bupivacaine USDMF includes data on Bupivacaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bupivacaine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bupivacaine suppliers with USDMF on PharmaCompass.
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