26-Apr-2016 - The savings will come from centralising manufacturing services and will complement the firm’s cost-saving business division launched last year.
25-Apr-2016 - The WHO has accused Semler Research of data fraud and said Mylan, Micro Labs, Lupin and Strides and others may need to repeat bioanalytical trials conducted by the CRO.
21-Apr-2016 - Sri Krishna Pharmaceuticals has been hit with a warning letter after the US FDA found problems with quality data at a site in Hyderabad, India.
21-Apr-2016 - The WHO has removed two APIs supplied by Anuh Pharma from its list of prequalified ingredients and announced plans to inspect the firm’s facility in Boisar, India.
20-Apr-2016 - Cell therapy and radiotracer production has halted at two facilities operated by the US National Institutes of Health (NIH) after consultants raised concerns about quality and manufacturing standards.
19-Apr-2016 - The US FDA has hit an Indian formulation facility run by Alembic Pharmaceuticals with a Form 483 with four observations.
18-Apr-2016 - The US FDA has issued draft guidance to address the recent torrent of data integrity problems at drug manufacturing sites.
14-Apr-2016 - Trade secret laws adopted by the European Parliament mean employees who raise concerns about drug safety and efficacy face legal uncertainty says HAI.
13-Apr-2016 - Inmunotek has been ordered to recall vaccines made at a facility in Madrid after Spanish regulators identified a number of GMP deficiencies.
11-Apr-2016 - IPCA has lost its supply agreement with the Global Fund just weeks after claiming to have “written confirmation” of an impending order.
04-Apr-2016 - Catalent has missed its forecast for bringing a suspended softgel facility back online, but says production of essential drugs has begun at the French plant.
04-Apr-2016 - Quality systems at a plant run by Rusan Pharma still break GMP rules according to a MHRA statement of non-compliance published this week.
31-Mar-2016 - The US FDA says it will not approve Opko's kidney disease drug Rayaldee until contract manufacturer Catalent fixes problems at its softgel plant in Florida.
31-Mar-2016 - The European Pharmacopeia Commission has adopted a revised monograph that allows a broader range of purification methods to be used for the production of water for injectable pharmaceuticals.
30-Mar-2016 - Cadila Healthcare has confirmed receipt of a notice of concern (NOC) about its vaccine plant in Moraiya, India five months after the WHO inspectors criticized operations.
30-Mar-2016 - Anuh Pharma has breached GMP rules at its API processing facility in Boisar, India say French regulators who visited the site last month.
21-Mar-2016 - The WHO has withdrawn a notice stripping Svizera Labs of prequalification status that it published in error last week.
21-Mar-2016 - The UK MHRA has accused Marksans Pharma of destroying manufacturing records and banned the Goa, India firm from supplying “non-critical” drugs.
21-Mar-2016 - Affymetrix has rejected a $1.5bn rival bid and said it prefers to merge with Thermo Fisher Scientific.
17-Mar-2016 - The US FDA has criticised operations at a Lupin manufacturing plant in Goa, India.
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