It’s been a busy year for API (active pharmaceutical ingredient) manufacturers with new facilities, cost pressures and regulatory developments all hitting the headlines.
And it seems recent developments in HPAPIs (high potency APIs) have caused a stir with news of the industry taking up the top 4 places of our end-of-year run-down.
Here are the most read API stories from in-PharmaTechnologist in 2011…
Carbogen Amcis' Indian plant received the regulatory thumbs up for the containment and handling of toxic APIs. Carbogen now handles all of Dishman’s HP API services.
Saltigo announced plans to further its HPAPI business. Currently finishing up expansions in the US – due for ribbon cutting in early 2012 – the Frankfurt, Germany-based firm also received Japanese regulatory accreditation for its intermediates site.
It was a big year for Carbogen, with another HPAPI development when they inked a deal with Pulymun Scientific. The partnership, signed in October, granted Carbogen access to the Austrian firm’s liposomal formulation tech.
Instead of going down the production route, Roche opened the doors to its facility in New Jersey, US, to process high potency compounds into drugs. The factory now deals with tablets, capsules, powders, suspensions and solutions for preclinical studies as well as Phase I and II trials.
Indian chemical maker Granules announced plans to expand manufacturing capacity for oral solid dose APIs in August. The company predicts a boom in finished dosage demand over the coming years.
Taiwanese API maker ScinoPharm took the business public in October in a bid to raise cash for upcoming expansions. The firm recently opened a plant in Changsu, Jiansgu in China and is planning more facilities in the next few years.
BASF made the headlines when it hiked the prices of APIs and excipients by 10 per cent twice in one year. The German chemical giant put the increase down to the rising costs of raw materials, energy and labour.
During a behind-the-scenes tour of its Glasgow plant, SAFC told in-PharmaTechnologist about its plans to focus on HPAPI production over the next year. The firm’s new aggressive growth strategy includes expansions in the US, Europe and developing markets.
Another firm increasing its API prices was Abermarle, which announced that its generic ingredients would be more costly as of October 2011. The company said it was “investing for the future” of the quality of its products.
And finally, the FDA and EMA decided to team up on facility inspection and have agreed to share data and duties from January 2012. The new collaboration was years in the pipeline, and follows recent results which suggest the move will reduce the number of duplicate inspections.