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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.
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.
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.
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.
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.
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