01 3Toray Industries
01 1BERAPROST SODIUM
02 1BPS-314d DRUG SUBSTANCE
03 1FACILITIES FOR THE MFG. OF BERAPROST SODIUM IN NAGOYA, JAPAN
01 3Japan
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14032
Submission : 1999-03-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24004
Submission : 2010-07-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9396
Submission : 1991-10-18
Status : Inactive
Type : II
A Beraprost Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Beraprost Sodium, including repackagers and relabelers. The FDA regulates Beraprost Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Beraprost 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 Beraprost Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Beraprost Sodium supplier is an individual or a company that provides Beraprost Sodium active pharmaceutical ingredient (API) or Beraprost Sodium finished formulations upon request. The Beraprost Sodium suppliers may include Beraprost Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Beraprost Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Beraprost Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Beraprost Sodium active pharmaceutical ingredient (API) in detail. Different forms of Beraprost Sodium DMFs exist exist since differing nations have different regulations, such as Beraprost Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Beraprost Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Beraprost Sodium USDMF includes data on Beraprost Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Beraprost Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Beraprost Sodium suppliers with USDMF on PharmaCompass.
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