01 1Maple Biotech
01 1PECTIN
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36058
Submission : 2021-07-10
Status : Active
Type : IV
A Pectin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pectin, including repackagers and relabelers. The FDA regulates Pectin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pectin 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 Pectin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pectin supplier is an individual or a company that provides Pectin active pharmaceutical ingredient (API) or Pectin finished formulations upon request. The Pectin suppliers may include Pectin API manufacturers, exporters, distributors and traders.
click here to find a list of Pectin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pectin DMF (Drug Master File) is a document detailing the whole manufacturing process of Pectin active pharmaceutical ingredient (API) in detail. Different forms of Pectin DMFs exist exist since differing nations have different regulations, such as Pectin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pectin DMF submitted to regulatory agencies in the US is known as a USDMF. Pectin USDMF includes data on Pectin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pectin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pectin suppliers with USDMF on PharmaCompass.
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