01 1Solara Active Pharma Sciences
02 1UQUIFA
03 1Vera Laboratories Ltd IN 500 004 Hyderabad
04 1Blank
01 2RANITIDINE
02 1RANITIDINE BASE
03 1RANITIDINE BULK DRUG
01 2India
02 1Spain
03 1Blank
01 4Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12543
Submission : 1997-06-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16251
Submission : 2002-11-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12501
Submission : 1997-05-08
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9080
Submission : 1991-04-26
Status : Inactive
Type : II
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Corporate PDF
A Ranitidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ranitidine, including repackagers and relabelers. The FDA regulates Ranitidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ranitidine 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 Ranitidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ranitidine supplier is an individual or a company that provides Ranitidine active pharmaceutical ingredient (API) or Ranitidine finished formulations upon request. The Ranitidine suppliers may include Ranitidine API manufacturers, exporters, distributors and traders.
click here to find a list of Ranitidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ranitidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ranitidine active pharmaceutical ingredient (API) in detail. Different forms of Ranitidine DMFs exist exist since differing nations have different regulations, such as Ranitidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ranitidine DMF submitted to regulatory agencies in the US is known as a USDMF. Ranitidine USDMF includes data on Ranitidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ranitidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ranitidine suppliers with USDMF on PharmaCompass.
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