International Journal For Multidisciplinary Research

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A Review on DMF Filing in EU, USA and Australia

Author(s) P. Shailaja, K. Sunil, V. Pushpalatha, G. Snehalatha, K. Satya Ashok
Country India
Abstract Drug master file (DMF) is highly confidential information describing the aspect elements and error free information regarding API and finished dosage form. It consists of two parts. One is open part and another one is restricted part. Open part contains the information about the quality of drug product by the licence holder. Prohibited part which is Closed part which is protect the secret and unofficial information about manufacturing of product which is relived In front of respect regulatory authorities. When two or more persons involved in manufacturing of pharmaceutical. The drug master file contains overall information about product quality, maturing stability and purity of the medicaments. Drug master file gives the support to the IND (Investigational New Drug) application, ANDA (Abbreviated New Drug Application), NDA. Every country has its own drug filling format and content. The current observation is different countries drug master filing, content of drug master filing and format of the filing respect countries.
Keywords API, IND, NDA, Investigational New Drug, Abbreviated New Drug Application, Drug Master File, DMF
Field Medical / Pharmacy
Published In Volume 4, Issue 5, September-October 2022
Published On 2022-09-03
Cite This A Review on DMF Filing in EU, USA and Australia - P. Shailaja, K. Sunil, V. Pushpalatha, G. Snehalatha, K. Satya Ashok - IJFMR Volume 4, Issue 5, September-October 2022. DOI 10.36948/ijfmr.2022.v04i05.009
DOI https://doi.org/10.36948/ijfmr.2022.v04i05.009
Short DOI https://doi.org/10/gqr494
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