Wednesday, April 17, 2013

Indian pharma expects US FDA’s SUPAC Mfg Eqpt Addendum to boost global regulatory compliance

Policy & Regulations

Nandita Vijay, Bengaluru
Friday, April 12, 2013, 08:00 Hrs [IST]
The Indian pharma industry expects the US FDA's recently released SUPAC (scale-up and post-approval changes): Manufacturing Equipment Addendum will further give fillip to faster clearances in plant audit and product approval. After releasing the Addendum, the US regulatory authority is seeking comments from the pharma industry before June 30, 2013.

India already has over 170 US FDA approved units and has bagged 178 Abbreviated New Drug Applications (ANDAs) in 2012 which is over 34 more than the 2011. These include companies from Aurobindo to Biocon, Dr Reddy’s Labs, Lupin, Sun, Indoco Remedies, Ranbaxy and Strides Arcolab. Now with a strong focus for generic drug prescriptions from the governments of US, European Union and Japan, there are many Indian companies exporting to these markets. Therefore the new draft guidelines on scale-up and post-approval changes: Manufacturing Equipment Addendum will only strengthen compliance to the global regulator’s requirements, said representatives from pharma industry.

The draft guidance combines the scale-up and post-approval changes for industry for the immediate release and modified release solid oral dosage forms and non-sterile semisolid dosage forms. It removes the lists of manufacturing equipment that were in both guidance and clarifies the types of processes being referenced.

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