2022
DOI: 10.22270/ijdra.v10i2.517
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Assessment of Regulatory requirements and filing procedure of Drug Master File for Brazil, Europe and South Africa

Abstract: A Drug Master File is a record that consists of detailed, correct data approximately an Active Pharmaceutical Ingredient (API) or Dosage Form of a Finished Product (FP). It is a classified document containing thorough, accurate, and up-to-date information regarding the active medicinal ingredient and medicament. A DMF is divided into two sections: (a) Open part (the Applicant's Part), which includes all of the details needed to determine the quality of a product. And (b) the Closed Part (Restricted Part). The … Show more

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