01 1SAFC
01 1ROSE BENGAL
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7149
Submission : 1987-09-14
Status : Inactive
Type : IV
A Rose Bengal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rose Bengal, including repackagers and relabelers. The FDA regulates Rose Bengal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rose Bengal 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 Rose Bengal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rose Bengal supplier is an individual or a company that provides Rose Bengal active pharmaceutical ingredient (API) or Rose Bengal finished formulations upon request. The Rose Bengal suppliers may include Rose Bengal API manufacturers, exporters, distributors and traders.
click here to find a list of Rose Bengal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rose Bengal DMF (Drug Master File) is a document detailing the whole manufacturing process of Rose Bengal active pharmaceutical ingredient (API) in detail. Different forms of Rose Bengal DMFs exist exist since differing nations have different regulations, such as Rose Bengal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rose Bengal DMF submitted to regulatory agencies in the US is known as a USDMF. Rose Bengal USDMF includes data on Rose Bengal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rose Bengal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rose Bengal suppliers with USDMF on PharmaCompass.
LOOKING FOR A SUPPLIER?