Nortec Quimica is the largest API manufacturer in Latin America.
01 1Nortec Quimica
02 1Moehs Iberica
03 1Actavis Inc
04 1Gufic Biosciences
05 1Siegfried AG
06 1Swati Spentose
01 2PRILOCAINE
02 1PRILOCAINE BASE
03 3PRILOCAINE USP
01 1Brazil
02 2India
03 1Ireland
04 1Spain
05 1Switzerland
01 5Active
02 1Inactive
01 4Complete
02 2Blank
Nortec Quimica is the largest API manufacturer in Latin America.
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-15
Pay. Date : 2017-12-06
DMF Number : 32283
Submission : 2017-12-07
Status : Active
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-28
Pay. Date : 2018-08-01
DMF Number : 32818
Submission : 2018-06-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-31
Pay. Date : 2018-04-29
DMF Number : 15772
Submission : 2001-12-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25252
Submission : 2011-08-30
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-19
Pay. Date : 2013-08-13
DMF Number : 14144
Submission : 1999-05-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35260
Submission : 2020-10-31
Status : Active
Type : II
A Prilocaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prilocaine, including repackagers and relabelers. The FDA regulates Prilocaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prilocaine 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 Prilocaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prilocaine supplier is an individual or a company that provides Prilocaine active pharmaceutical ingredient (API) or Prilocaine finished formulations upon request. The Prilocaine suppliers may include Prilocaine API manufacturers, exporters, distributors and traders.
click here to find a list of Prilocaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prilocaine DMF (Drug Master File) is a document detailing the whole manufacturing process of Prilocaine active pharmaceutical ingredient (API) in detail. Different forms of Prilocaine DMFs exist exist since differing nations have different regulations, such as Prilocaine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prilocaine DMF submitted to regulatory agencies in the US is known as a USDMF. Prilocaine USDMF includes data on Prilocaine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prilocaine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prilocaine suppliers with USDMF on PharmaCompass.
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