Nortec Quimica is the largest API manufacturer in Latin America.
01 1Nortec Quimica
02 1Seqens
03 1Supriya Lifescience
04 1Alkem Laboratories
05 1Arevipharma
06 1Maithri Drugs
Nortec Quimica is the largest API manufacturer in Latin America.
GDUFA
DMF Review : Complete
Rev. Date : 2023-02-22
Pay. Date : 2023-01-31
DMF Number : 37647
Submission : 2022-12-09
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16737
Submission : 2003-07-31
Status :
Type : II
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36426
Submission : 2021-11-08
Status :
Type : II
A (-)-Ketamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (-)-Ketamine, including repackagers and relabelers. The FDA regulates (-)-Ketamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (-)-Ketamine 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 (-)-Ketamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (-)-Ketamine supplier is an individual or a company that provides (-)-Ketamine active pharmaceutical ingredient (API) or (-)-Ketamine finished formulations upon request. The (-)-Ketamine suppliers may include (-)-Ketamine API manufacturers, exporters, distributors and traders.
click here to find a list of (-)-Ketamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (-)-Ketamine DMF (Drug Master File) is a document detailing the whole manufacturing process of (-)-Ketamine active pharmaceutical ingredient (API) in detail. Different forms of (-)-Ketamine DMFs exist exist since differing nations have different regulations, such as (-)-Ketamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (-)-Ketamine DMF submitted to regulatory agencies in the US is known as a USDMF. (-)-Ketamine USDMF includes data on (-)-Ketamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (-)-Ketamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (-)-Ketamine suppliers with USDMF on PharmaCompass.
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