01 1Cipla
02 1Jinzhou Jiutai Pharmaceutical
03 1Sterile India Pvt. Ltd
01 2OMEPRAZOLE SODIUM
02 1OMEPRAZOLE SODIUM (STERILE)
01 1China
02 2India
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20169
Submission : 2007-01-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33402
Submission : 2018-12-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29981
Submission : 2016-11-28
Status : Active
Type : II
A Omeprazole Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omeprazole Sodium, including repackagers and relabelers. The FDA regulates Omeprazole Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omeprazole Sodium 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 Omeprazole Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Omeprazole Sodium supplier is an individual or a company that provides Omeprazole Sodium active pharmaceutical ingredient (API) or Omeprazole Sodium finished formulations upon request. The Omeprazole Sodium suppliers may include Omeprazole Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Omeprazole Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Omeprazole Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Omeprazole Sodium active pharmaceutical ingredient (API) in detail. Different forms of Omeprazole Sodium DMFs exist exist since differing nations have different regulations, such as Omeprazole Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Omeprazole Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Omeprazole Sodium USDMF includes data on Omeprazole Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Omeprazole Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Omeprazole Sodium suppliers with USDMF on PharmaCompass.
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