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Set Alert for Manufacturing

European Council Brings SPC Manufacturing Waiver A Step Closer

A proposed SPC manufacturing waiver – which would allow generic and biosimilar manufacturing within Europe during the SPC period – has taken a step closer to being realized after the European Council approved a mandate for negotiations with the European Parliament. However, it remains uncertain whether key elements desired by the off-patent industry will fall into place.

Europe Manufacturing

Manufacturing Roundup – 17 January 2019

Dr Reddy’s is hit with a manufacturing setback after getting issued a Form 483 report for its site in Andhra Pradesh, India, while several firms announce site expansions, including in Spain and the US.

Companies Manufacturing

Pfizer To Close Two Former Hospira Sites In India

Pfizer is set to close two of its manufacturing facilities in India this year, after the firm concluded that production at the former Hospira sites “is not viable” due to falling demand.

India Generic Drugs

Akorn Hit With FDA Warning For Decatur Site In US

Akorn has again been pulled up by the FDA for deficiencies at its US manufacturing plant in Decatur, Illinois, concerning aseptic practices and cleaning procedures. Last year, the firm was issued a Form 483 inspection report for the site; now, it has been struck with an FDA warning letter.

United States Manufacturing

Senator Wants US Government To Make Generics

Public manufacturing of generics would drive down prices and alleviate shortages, according to legislation tabled by US Democratic Senator Elizabeth Warren.
Manufacturing Legislation

Manufacturing Roundup – 21 December 2018

The first pharmaceutical manufacturing plant is inaugurated in the UAE’s Dubai Science Park, while Recipharm discusses potentially closing its UK solid-dose manufacturing site. Two Indian firms clear FDA audits with no observations, and Idifarma is ready for next year’s serialization requirements.

Companies Manufacturing
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