Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application reviewers, according to a report from the HHS Office...
Ranbaxy must sell its acne drug minocycline to Torrent Pharmaceuticals and support the firm while it gains regulatory approval for its API supplier before the US Federal Trade Commission will allow Sun Pharmaceutical Industries to complete its $4bn takeover.
BASF will spend €56m ($62m) to increase production capacity for the excipient PVP by expanding existing plants and introducing manufacturing capabilities at its facility in Shanghai, China.
Codexis has felt the impact of Gilead’s Sovaldi with product revenues tumbling almost 60% due to the reduction in its hepatitis C biocatalyst and intermediate business.
US and foreign API facilities will see their annual US FDA facility fees rise more than $5,000, while their FDF (fixed-dose form) counterparts will see their fees rise by more than $20,000.
Switching patients to generic pills of a different shape and colour increases the chances they will end their course of medicine early, according to research.
With generic drugs covering 80% of all dispensed drugs in the US, Democrats and Republicans seem split over a proposed FDA rule that would allow generic manufacturers to submit labelling changes within 30 days after discovering a new adverse event or...
The US Department of Justice is supplementing financial punishments for pharmaceutical companies violating FDA rules with corporate integrity agreements (CIAs), said the US Assistant Attorney General.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has withdrawn its good manufacturing practice certificate for Wockhardt’s Chikalthana, India-based plant due to cGMP violations.
After more than a year delay, IPEC India is expected to be created by the end of the year after IPEC-Americas’ vice chair confirmed that the registration process is moving forward.
After finding cGMP violations at another Ranbaxy plant in India, the US FDA on Monday issued an import alert that effectively stops all of the plant’s drug shipments from entering the US.
The US FDA has released a Q&A to offer more clarity to GPhA, Cipla, Akorn and other drug and API manufacturers who responded to the initial stability draft guidance for ANDAs.
US and foreign generic drug manufacturers will see a more than $40,000 increase in US FDA facility fees for 2014, while API manufacturers will see a more than $8,000 increase.
The US FDA has amended the list of draft guidance documents it expects to release for the rest of the year with two new guidance topics, one deleted guidance and a few other hotly-anticipated documents still to come.
In the largest US generic drug safety settlement ever, Ranbaxy USA has agreed to pay $500m after pleading guilty to manufacturing and distributing adulterated drugs, according to the US Justice Department settlement agreement.
The US FDA is giving generic drug facilities one month to self-identify for FY 2014 so that the agency can calculate how much to charge the companies in user fees for application reviews and inspections.
President Obama’s FY 2014 budget request of $4.7B for the US FDA would increase the agency’s ability to inspect foreign drug manufacturers and clinical trial sites.
Formulations of two ophthalmic drugs have become the first exports to Europe from Bangladeshi company Beximco as they seek to expand into the EU market.
Foreign generic drug and API manufacturers will have to pay $15,000 more than their US counterparts because of additional costs required for the US Food and Drug Administration (FDA) to inspect the overseas facilities.
The GDUFA ‘self-identification’ requirement for generic API plants is not a flawed idea says SOCMA’s BDTF after FDA extends registration deadline citing fewer than expected registrations.
CROs conducting bioequivalence and bioavailability (BE/BA) studies for generics firms will have to log details of their sites with the US FDA under new ‘self-identification’ rules.
Generic API (active pharmaceutical ingredient) makers should consider the off-patent potential of a drug as soon as it is launched, according to a new study by PharmaIntellect.
Watson Pharmaceuticals has bought Greek generics firm Specifar Pharmaceuticals, bringing to an end a busy month of deal making in the non-branded drug sector.
Indian-based drug makers continue to come under intense scrutiny by the US Food and Drug Administration (FDA) as the regulatory body issues warnings to healthcare professionals not to use certain brands of antibiotics due to potential contamination.
The US FDA says Teva Pharmaceutical Industries’ plan to fix cGMP violations observed at its plant in Irving, California “lack sufficient corrective actions.”
Ranbaxy Laboratories has sold its Chinese JV, Ranbaxy Guangzhou China Limited (RGCL), as part of a new approach to the country’s rapidly expanding drug market.
Teva will continue to use Codexis’ biocatalysis technology for key processing steps in the production of four generic drugs under a revised agreement announced last week.
Israeli generics giant Teva Pharmaceutical Industries will close one of its manufacturing plants in the Czech Republic by the end of the year, resulting in the loss of around 400 jobs.
Watson Pharmaceuticals is to acquire Arrow Group for $1.75bn (€1.26bn), adding to the company’s manufacturing network and providing it with the expertise needed to enter the biogenerics market.
The US subsidiary of world leading generics firm Teva Pharmaceutical Industries has called in procurement specialist ICG Commerce to help it cut its outsourcing spend as part of ongoing cost reduction operations.
The US authorities are turning up the heat on Icelandic generic drugmaker Actavis over manufacturing problems at the New Jersey plant which makes its recalled Digitek brand of the cardiac drug digoxin.
