01 1Apollo Ingredients India Pvt Ltd
02 1Newgen Biotech USA
03 1Blank
01 1BROMELAIN
02 1BROMELAIN - COMMERICAL GRADE MF'G PROCEDURES
03 1BROMELAIN 5000 GDU
01 1India
02 1U.S.A
03 1Blank
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35092
Submission : 2020-08-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27173
Submission : 2013-05-06
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 391
Submission : 1960-07-18
Status : Inactive
Type : II
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A Bromelain manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromelain, including repackagers and relabelers. The FDA regulates Bromelain manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromelain 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 Bromelain manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bromelain supplier is an individual or a company that provides Bromelain active pharmaceutical ingredient (API) or Bromelain finished formulations upon request. The Bromelain suppliers may include Bromelain API manufacturers, exporters, distributors and traders.
click here to find a list of Bromelain suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bromelain DMF (Drug Master File) is a document detailing the whole manufacturing process of Bromelain active pharmaceutical ingredient (API) in detail. Different forms of Bromelain DMFs exist exist since differing nations have different regulations, such as Bromelain USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bromelain DMF submitted to regulatory agencies in the US is known as a USDMF. Bromelain USDMF includes data on Bromelain's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bromelain USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bromelain suppliers with USDMF on PharmaCompass.
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