Manufacturing and production news in brief
pharmafile | July 5, 2013 | News story | Manufacturing and Production |Â Â Almac, Elona Biotech, Kamada, King Pharmaceuticals, Shasun Pharma, Tianyin PharmaÂ
A round-up of recent developments in the pharma manufacturing sector, including a fine for King Pharma, a strike at a Shasun API unit and facility updates from Almac, Elona, Tianyin Pharma and Kamada.
Pfizer subsidiary King Pharmaceuticals has been fined $2.2 million in civil penalties for violating the US Clean Air Act at its solid and semi-solid dosage form plant in Bristol, Tennessee. The infractions were found during an inspection of the facility in 2006 by state and federal environment agencies. News of the fine comes around a month after Pfizer sold off the 500,000 sq. ft. Bristol site to UPM Pharmaceuticals.
A strike at an active pharmaceutical ingredient (API) manufacturing plant operated by India’s Shasun Pharmaceuticals – which got underway last month, has now been called off. The Pondicherry facility makes ibuprofen and other APIs and finished formulations, and it has been estimated by local news sources that the industrial action cost Shasun around 200m rupees (around $3m).
Almac has introduced contained drug handling and bottling capabilities at its clinical trial supply facilities in Craigavon, Northern Ireland, and Souderton in the US in response to increased demand for handling of high-potency compounds. The facilities have been installed and validated and available for companies who need to fill potent pipeline products.
The local authorities in Greenwood, Indianapolis, have filed a foreclosure lawsuit against Elona Biotechnologies for failing to open a promised manufacturing facility in the city, despite receiving $8.4 million in loans and other forms of financial assistance. Elona – which specialises in protein purification and process development services – had originally said it would invest $25 million in the proposed plant, which was expected to employ around 70 workers.
The Israeli Ministry of Health has completed a good manufacturing practice (GMP) audit of biopharmaceutical company Kamada‘s manufacturing facility in Beit Kama, Israel. The audit confirmed the unit’s compliance with GMP requirements for the manufacture of medicinal products, the importation of medicinal products and the manufacture of active substances using biological processes. Kamada sells more than ten injectable pharmaceutical products which are marketed in more than 15 countries worldwide.
China’s Tianyin Pharmaceutical says construction of its Qionglai Facility (QLF) – a pre-extraction and formulation plant used to make traditional Chinese medicine (TCM) ingredients from natural herbs – has now been completed and is due for inspection by the State Food and Drug Administration (SFDA) in August.
Phil Taylor
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