01 1Colorcon Inc
01 1POLYVINYL ACETATE PHTHALATE
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 967
Submission : 1965-12-21
Status : Active
Type : IV
13
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A Polyvinyl Acetate Phthalate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polyvinyl Acetate Phthalate, including repackagers and relabelers. The FDA regulates Polyvinyl Acetate Phthalate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polyvinyl Acetate Phthalate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Polyvinyl Acetate Phthalate supplier is an individual or a company that provides Polyvinyl Acetate Phthalate active pharmaceutical ingredient (API) or Polyvinyl Acetate Phthalate finished formulations upon request. The Polyvinyl Acetate Phthalate suppliers may include Polyvinyl Acetate Phthalate API manufacturers, exporters, distributors and traders.
click here to find a list of Polyvinyl Acetate Phthalate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Polyvinyl Acetate Phthalate DMF (Drug Master File) is a document detailing the whole manufacturing process of Polyvinyl Acetate Phthalate active pharmaceutical ingredient (API) in detail. Different forms of Polyvinyl Acetate Phthalate DMFs exist exist since differing nations have different regulations, such as Polyvinyl Acetate Phthalate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polyvinyl Acetate Phthalate DMF submitted to regulatory agencies in the US is known as a USDMF. Polyvinyl Acetate Phthalate USDMF includes data on Polyvinyl Acetate Phthalate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polyvinyl Acetate Phthalate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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