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THE PHARMA REVIEW (MAY - JUNE 2012)

Dynamics of Drug Master Filings at United States Food and Drug Administration

Rau. B. S, Appaji P. V

Abstract: Drug master filing at USFDA in one of the parameters that helps in knowing the potentiality of a country in the field of pharmaceuticals. Filing a drug master file at USFDA implies that the company is claiming manufacturing drug and facility suitable for USFDA rules and regulations. Several incidences are available where a company do have a USFDA approved facility but do not have financial viability of the developed products. Patent Facilitation Center at Pharmexcil of India believes that providing lead information to develop innovative products finally leads to protection of intellectual property. The article mainly concentrates statistics relating to type II drug master filing at USFDA since manufacturing drugs in USFDA approved facilities usually comply global standards.
 
Introduction
As per the regulatory guidelines, it is mandatory to file a drug master file and after being approved, releasing the drug into the market. A drug master file may be for a bulk drug or for a formulation. A drug master file declared by the company provides in detail the manufacturing place, physicochemical properties, pharmacodynamic/kinetic, toxicology studies of the bulk drugs and formulations, therapeutic class, dosage form, strength, route of administration, labeling, packaging etc. Filing a drug master file at USFDA by a company is an indication that the company is claiming its capability in manufacturing and having a facility complying USFDA rules and regulations.
Filing drug master files from countries other than United States, give a provision to the US pharmaceutical organizations recommending foreign country facilities utilizing the manufactured products upon approval by the USFDA authorities to market in United States.
It is necessary to understand DMF filings by pharmaceutical industries give an indication of potential market both in terms of volume and value.

 

 

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