01 1Sichuan Xieli Pharmaceutical
02 1Sunpure Extracts
01 1BERBERINE HYDROCHLORIDE
02 1BERBERINE HYDROCHLORIDE EXTRACT 95%
01 1China
02 1India
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35391
Submission : 2020-11-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38587
Submission : 2023-07-05
Status : Active
Type : II
A Berberine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Berberine Hydrochloride, including repackagers and relabelers. The FDA regulates Berberine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Berberine Hydrochloride 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 Berberine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Berberine Hydrochloride supplier is an individual or a company that provides Berberine Hydrochloride active pharmaceutical ingredient (API) or Berberine Hydrochloride finished formulations upon request. The Berberine Hydrochloride suppliers may include Berberine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Berberine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Berberine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Berberine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Berberine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Berberine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Berberine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Berberine Hydrochloride USDMF includes data on Berberine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Berberine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Berberine Hydrochloride suppliers with USDMF on PharmaCompass.
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