Pharma manufacturing news in brief
pharmafile | January 31, 2012 | News story | Manufacturing and Production |Â Â Aptar Pharma, Granules-Omnichem, Lpath, Pii, ShembergÂ
Facility updates from Aptar Pharma, Granules-Omnichem and Pii, plus a fill/finish problem for Lpath and seaweed-based pharma capsules.
Aptar Pharma has opened a new manufacturing site in Mumbai, India, its second in Asia after Suzhou in China and seventh worldwide. The specialist in nasal and pulmonary drug delivery devices said the new plant includes an ISO 7 cleanroom, where main production will focus on its DF30 metering valve platform for metered dose inhalers and on spray pump assembly.
Granules-Omnichem, a joint venture set up last year by Granules India and Ajinomoto Omnichem, says it will start construction in early February of a new active pharmaceutical ingredient (API) and intermediate manufacturing facility in Visakhapatnam, Andhra Pradesh, which is scheduled to start production in 2013. It will initially serve the needs of Omnichem’s existing customers and eventually moving on to custom manufacture of new chemical entities.
US drug development company Lpath Inc has been forced to suspend patient dosing in two Phase II clinical trials of its iSONEP treatment for two eye diseases – age-related macular degeneration and pigmented epithelial detachment – because of quality compliance issues at its fill/finish contractor Formatech. The company is in the process of finding a new fill/finish contractor for the iSONEP programme, which is partnered with Pfizer.
Pharmaceutics International Inc (Pii) has started construction of a new 24,000 sq. ft. aseptic fill/finish manufacturing facility at its site in Maryland, US. The new facility will more than double capacity sterile GMP production capacity, said the company, which expects to complete the expansion before the end of 2012. The fill/finish suites will feature automated vial and syringe filling, inspection and labelling equipment capable of producing batch sizes of 100,000-plus units.
Seaweed specialist Shemberg Marketing Corp of the Philippines is trying to forge alliances with pharmaceutical capsule suppliers to help develop softgel capsules based on seaweed constituents such as carrageenan. The company is already carrying out test production runs and hopes to have a commercial-scale process worked out within the next six months, it said.
Phil Taylor
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