01 1Kyowa Hakko Bio
02 1Optimus Pharma
03 1Santen Pharmaceutical
01 1BUCILLAMINE
02 1BUCILLAMINE BULK SUBSTANCE
03 1RIMATIL
01 1India
02 2Japan
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12270
Submission : 1996-11-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36652
Submission : 2021-12-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9589
Submission : 1992-03-19
Status : Inactive
Type : II
A Bucillamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bucillamine, including repackagers and relabelers. The FDA regulates Bucillamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bucillamine 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 Bucillamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bucillamine supplier is an individual or a company that provides Bucillamine active pharmaceutical ingredient (API) or Bucillamine finished formulations upon request. The Bucillamine suppliers may include Bucillamine API manufacturers, exporters, distributors and traders.
click here to find a list of Bucillamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bucillamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Bucillamine active pharmaceutical ingredient (API) in detail. Different forms of Bucillamine DMFs exist exist since differing nations have different regulations, such as Bucillamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bucillamine DMF submitted to regulatory agencies in the US is known as a USDMF. Bucillamine USDMF includes data on Bucillamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bucillamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bucillamine suppliers with USDMF on PharmaCompass.
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