Pharma manufacturing news in brief
pharmafile | May 1, 2012 | News story | Manufacturing and Production |Â Â Aptar Pharma, Ark Therapeutics, Cambrex, Eckert & Ziegler, Granules India and Omkar Speciality ChemicalsÂ
Cambrex facility passes FDA inspection, low-cost inhaler launched by Aptar, plus updates from Eckert & Ziegler, Granules India and Omkar Speciality Chemicals.
US Food and Drug Administration (FDA) inspectors have given a green light to Cambrex‘ active pharmaceutical ingredient (API) manufacturing facility in Charles City, Iowa, after visiting the site in February. The GMP certification follows similar positive inspections by the authorities in the UK and Korea. The Charles City site has an advanced high-potency development centre as well as API commercial capabilities with a large-scale cGMP facility, R&D labs and warehousing.
Aptar Pharma has launched a new delivery device for respiratory medicines called the Twister, billed as an affordable capsule-based dry powder inhaler (DPI) device specifically targeting fast-growing, emerging markets which have traditionally tended to rely on the use of pressurised metered dose inhalers (pMDIs). The device is manufactured in China and is being pitched as an off-the-shelf device that can be used with a variety of different drug compounds and formulations.
Radioisotope specialist Eckert & Ziegler has started the construction of a new production facility for cyclotron-based PET radiopharmaceuticals in Warsaw, Poland. The company said it plans to invest around €7 million in cyclotron for commercial production of FDG (fludeoxyglucose 18F) and other tracers for cancer imaging diagnostics, and will also construct GMP laboratories for R&D of new radio-diagnostic agents at the site.
UK-based Ark Therapeutics says that the Finnish Medicines Agency (FIMEA) has extended the company’s Good Manufacturing Practice (GMP) certification to include its newest and largest production facility, known as GMP 3. The new 650 sq. m. unit has greatly increased Ark’s manufacturing capacity, with an automated fill-and-finish line capable of handling up to 2,000 product units/hour. Meanwhile, Ark has appointed Dr David Venables to the role of executive director of manufacturing services.
Contract manufacturer and active pharmaceutical ingredient producer Granules India has appointed VVS Murthy as its new chief financial officer. Meanwhile, current CFO Pranesh Raj Mathur will step aside but continue his role as president of the company’s API division, according to the firm. Murthy joins Granules India from Dishman Pharma, where he was also CFO.
India’s Omkar Speciality Chemicals has made a foray into the pharmaceutical ingredient business via the acquisition LASA Laboratory, another Indian company which specialises in manufacturing various antihelmintic compounds such as benzimidazoles, as well as other APIs.
Phil Taylor
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