01 1AANJANEYA LIFECARE LIMITED IN
02 1Buchler GmbH
03 1PT KIMIA FARMA PERSERO TBK
04 1PT Sinkona
05 1Roche Diagnostics GmbH
06 1SM Herbals Pvt Ltd
07 1Vital Laboratories Private Limited
01 2QUININE SULFATE
02 2QUININE SULFATE USP
03 1QUININE SULFATE, USP
04 1QUININE SULPHATE USP
05 1QUININE SULPHATE USP DRUG SUBSTANCE
01 2Germany
02 3India
03 2Indonesia
01 2Active
02 5Inactive
01 1Complete
02 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23415
Submission : 2009-12-15
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-24
Pay. Date : 2013-06-14
DMF Number : 17086
Submission : 2004-01-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20951
Submission : 2007-09-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19905
Submission : 2006-10-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9462
Submission : 1991-12-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31629
Submission : 2017-04-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24063
Submission : 2010-07-19
Status : Active
Type : II
A (-)-Quinine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (-)-Quinine, including repackagers and relabelers. The FDA regulates (-)-Quinine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (-)-Quinine 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 (-)-Quinine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (-)-Quinine supplier is an individual or a company that provides (-)-Quinine active pharmaceutical ingredient (API) or (-)-Quinine finished formulations upon request. The (-)-Quinine suppliers may include (-)-Quinine API manufacturers, exporters, distributors and traders.
click here to find a list of (-)-Quinine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (-)-Quinine DMF (Drug Master File) is a document detailing the whole manufacturing process of (-)-Quinine active pharmaceutical ingredient (API) in detail. Different forms of (-)-Quinine DMFs exist exist since differing nations have different regulations, such as (-)-Quinine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (-)-Quinine DMF submitted to regulatory agencies in the US is known as a USDMF. (-)-Quinine USDMF includes data on (-)-Quinine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (-)-Quinine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (-)-Quinine suppliers with USDMF on PharmaCompass.
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