01 2Buchler GmbH
02 1PT KIMIA FARMA PERSERO TBK
03 1PT Sinkona
04 1Plantex Ltd.
05 1Blank
01 1QUINIDINE SALTS
02 3QUINIDINE SULFATE
03 1QUINIDINE SULFATE AND QUINIDINE PRODUCTS
04 1QUINIDINE SULPHATE USP 19
01 2Germany
02 2Indonesia
03 1Israel
04 1Blank
01 1Active
02 5Inactive
01 1Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-13
Pay. Date : 2013-08-02
DMF Number : 3677
Submission : 1979-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2759
Submission : 1976-08-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2871
Submission : 1977-02-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3066
Submission : 1977-10-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9632
Submission : 1992-03-30
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3146
Submission : 1978-03-10
Status : Inactive
Type : II
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A Quinidine sulphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quinidine sulphate, including repackagers and relabelers. The FDA regulates Quinidine sulphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quinidine sulphate 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 Quinidine sulphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Quinidine sulphate supplier is an individual or a company that provides Quinidine sulphate active pharmaceutical ingredient (API) or Quinidine sulphate finished formulations upon request. The Quinidine sulphate suppliers may include Quinidine sulphate API manufacturers, exporters, distributors and traders.
click here to find a list of Quinidine sulphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Quinidine sulphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Quinidine sulphate active pharmaceutical ingredient (API) in detail. Different forms of Quinidine sulphate DMFs exist exist since differing nations have different regulations, such as Quinidine sulphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quinidine sulphate DMF submitted to regulatory agencies in the US is known as a USDMF. Quinidine sulphate USDMF includes data on Quinidine sulphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quinidine sulphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Quinidine sulphate suppliers with USDMF on PharmaCompass.
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