01 1Sunpure Extracts
01 1COLEUS FORSKOHLII EXTRACT 98%
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39173
Submission : 2023-11-20
Status : Active
Type : II
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A Forskolin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Forskolin, including repackagers and relabelers. The FDA regulates Forskolin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Forskolin 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 Forskolin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Forskolin supplier is an individual or a company that provides Forskolin active pharmaceutical ingredient (API) or Forskolin finished formulations upon request. The Forskolin suppliers may include Forskolin API manufacturers, exporters, distributors and traders.
click here to find a list of Forskolin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Forskolin DMF (Drug Master File) is a document detailing the whole manufacturing process of Forskolin active pharmaceutical ingredient (API) in detail. Different forms of Forskolin DMFs exist exist since differing nations have different regulations, such as Forskolin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Forskolin DMF submitted to regulatory agencies in the US is known as a USDMF. Forskolin USDMF includes data on Forskolin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Forskolin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Forskolin suppliers with USDMF on PharmaCompass.
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