01 1Bayer AG
02 1Buchler GmbH
03 1Forest Laboratories
04 1Island Pharmaceuticals
05 1PT Sinkona
06 1Roche Diagnostics GmbH
07 2Blank
01 5QUINIDINE GLUCONATE
02 1QUINIDINE GLUCONATE & SULFATE USP XIX (BULK) & BP 1973
03 1QUINIDINE GLUCONATE 650 MG. C.R. TABLETS
04 1QUINIDINE GLUCONATE EXTENDED RELEASE GRANULES
01 1Australia
02 3Germany
03 1Indonesia
04 1U.S.A
05 2Blank
01 1Active
02 7Inactive
01 1Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5062
Submission : 1983-07-14
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-15
Pay. Date : 2018-08-10
DMF Number : 32527
Submission : 2018-03-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5904
Submission : 1985-07-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3697
Submission : 1980-01-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12334
Submission : 1997-01-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3355
Submission : 1978-10-13
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2723
Submission : 1976-08-05
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7292
Submission : 1988-01-15
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Quinidine Gluconate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quinidine Gluconate, including repackagers and relabelers. The FDA regulates Quinidine Gluconate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quinidine Gluconate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Quinidine Gluconate supplier is an individual or a company that provides Quinidine Gluconate active pharmaceutical ingredient (API) or Quinidine Gluconate finished formulations upon request. The Quinidine Gluconate suppliers may include Quinidine Gluconate API manufacturers, exporters, distributors and traders.
click here to find a list of Quinidine Gluconate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Quinidine Gluconate DMF (Drug Master File) is a document detailing the whole manufacturing process of Quinidine Gluconate active pharmaceutical ingredient (API) in detail. Different forms of Quinidine Gluconate DMFs exist exist since differing nations have different regulations, such as Quinidine Gluconate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quinidine Gluconate DMF submitted to regulatory agencies in the US is known as a USDMF. Quinidine Gluconate USDMF includes data on Quinidine Gluconate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quinidine Gluconate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Quinidine Gluconate suppliers with USDMF on PharmaCompass.
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