A French subsidiary of specialty ingredients firm Seppic has become the latest supplier certified under the Excipact quality scheme for drug excipients
Daiichi-Sankyo says ensuring API supply could be a problem at Ranbaxy’s US finished product sites after imports are banned from yet another of its Indian facilities.
Higher earnings and improved margins did not impress investors in Lonza, which saw its share price tumble today after revealing that sales to the drug sector fell in 2013.
Increased in-house API production and manufacturing in India will lower the costs of Hospira’s injectables, the firm says, as it looks past current remediation efforts.
European dependence on drugs and APIs made outside the EU is still ‘alarming’ despite recently introduced anti-falsified meds laws according to the European Fine Chemicals Group (EFCG).
AMRI says it intends to expand its fill/finish capability and progress its business into higher value technology following the recent all clear at its once troubled Burlington facility.
Drugs containing APIs derived from cannabis plants are a far cry from the non-clinical approach of marijuana dispensaries, says GWPharma, as France approves Sativex.
Patheon is the world’s largest pharmaceutical development services (PDS) provider and third largest contract manufacturer, according to a report released yesterday.
Chinese API firm Shenzhen Hepalink has announced plans to buy Scientific Protein Laboratories (SPL) from private equity investor American Capital for $337.5m.
Encap has collaborated with Lipocine to manufacture its oral testosterone product and says it expects continued growth in demand for HPAPI formulation services.
Elder Pharmaceuticals has agreed to sell its branded drug portfolio to Torrent Pharmaceuticals in a deal that will refocus the firm as a CMO and anti-infectives producer.
B Braun Melsungen AG has changed the type of stoppers used to seal its injectable metabolic acidosis treatment, sodium bicarbonate, after quality problems that resulted in a UK MHRA alert last week.
A lawsuit alleging that the US FDA unlawfully detained a batch of acetaminophen API destined for CMO Gemini Pharmaceuticals could have significant impact on the drug industry's definition of an ‘end user.'
Actavis says it is restructuring a Californian manufacturing facility at a cost of 56 jobs weeks after the announced closure of a plant in North Carolina.
Royal DSM wants to merge its pharmaceutical products business with Patheon and has signed a deal with the latter's owner, investment group JLL Partners.
GSK has announced plans for a new manufacturing plant to "bring more medicines to the people of India" weeks after revealing that some drug wholesalers in the country have stopped buying its products.
Concerns recently introduced import laws would cause EU-wide API shortages now appear unfounded, but European industry groups say the buffering effects of stockpiling mean it is still too early to be sure supplies will not be affected.
A third Amarin supplier has confirmed it will continue to supply the firm with pharma-grade omega-3 despite a US FDA panel recommending against a label extension for the heart pill Vascepa.
DSM says it has not found the right partner for its pharmaceutical products business and is continuing to look for a collaborator with which it can grow in Asia.
An IPEC-affiliated coalition is calling on USP (US Pharmacopoeia) to allow for the determination of physiologically relevant bioaccessible elemental impurity content for pharmaceutical products and components.
Granules India has outlined plans to buy drug intermediate and API maker Auctus Pharma, set up an actives R&D site and announced its intention to wind up its ‘shell’ operation in Singapore.
Lonza says its pharmaceutical business ‘performed as expected’ in the third quarter and that its restructuring efforts – which have seen it cut nearly 800 jobs– are on track to deliver productivity gains.
API, drug intermediates and formulations firm Granules India ended the second quarter of fiscal 2013 with higher revenue and profit thanks to gains made by all three of its units.
Regulatory pressure for risk-based supply chain management is increasing excipient suppliers’ audit burden according to the team preparing to launch the 'excipact' certification scheme as an independent association.
Omega-3 supplier BASF will continue to produce the API for Amarin, as well as its competitor GlaxoSmithKline, despite an FDA panel saying that Amarin’s drug should not be approved for a broader population.
Azelis says its partnership with JH Nanhang (JHNH) will feed a large demand for polyvinylpyrolidones (PVP) excipients and bring the China-made ingredients to new markets.
Cirrus Pharmaceuticals has received a grant to investigate the effect of excipient concentration and API molecule size on metered dose inhaler (MDI) formulations.
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.
