Manufacturing and production news in brief
pharmafile | September 6, 2013 | News story | Manufacturing and Production |Â Â GSK, Jabones Pardo, Mylan, Shasun, WockhardtÂ
A round-up of pharma manufacturing facility news, with updates from Wockhardt, Mylan, GSK and Shasun, plus an FDA warning letter for Spain’s Jabones Pardo.
Wockhardt has decided to shift production of products destined for the US market from its troubled facility in Waluj, Aurangabad – which is currently the subject of an import alert by the FDA as well as a warning letter – to another facility in Shendra, Maharashtra. The Waluj facility also failed an inspection by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) earlier this year. The company expects the transfer to result in a financial charge of around $100 million, according to an Economic Times report.
US generic drugmaker Mylan has completed construction of an 85,000 sq. ft. transdermal patch facility in St. Albans, Vermont, that could create 160 new jobs. The expansion takes production capacity at the company’s Mylan Technologies Inc (MTI) drug delivery subsidiary to a total of 391,000 sq. ft., which chief executive Heather Bresch said would assist “in the expansion and diversification of Mylan’s global product portfolio, especially when it comes to difficult-to-develop and manufacture products”.
GlaxoSmithKline has received offers to purchase a manufacturing facility in Brasov, Romania, which has been under threat of closure since June, according to local press reports. The Europharm plant employs around 250 workers and is said to be the second-largest pharma facility in Romania, making 16 products including drugs for HIV, depression and respiratory diseases, with sales of around €100 million last year, according to a Romania-Insider.com report, which cites business news site Zf.ro. The products made at Brasov have seen turnover decline thanks to patent expirations, leading to surplus capacity.
India’s Shasun Pharmaceuticals says it successfully passed a Good Manufacturing Practice (GMP) inspection by the MHRA of its formulations facility last month. The facility in Puducherry has also passed earlier inspections by the FDA and Brazilian health regulator ANVISA, said the company. Shasun has been expanding into formulations in recent years to complement its activities in manufacturing active pharmaceutical ingredients and intermediates, with a particular focus on complex formulations and providing development services to contract manufacturing clients.
Spanish company Jabones Pardo SA has been sent a warning letter by the FDA after an inspection of a facility in Fuenlabrada, Madrid. The inspection uncovered a number of issues involving over-the-counter products made at the plant, including a failure to carry out adequate testing for active ingredient levels and other specifications in an acne cream that is sold in the US under the Le’dermis brand. Other quality control failures were also revealed by the inspection, said the agency in the letter. Jabones Pardo is also upbraided for selling unapproved and misbranded OTC drugs in the US.
Phil Taylor
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