Pharma manufacturing news in brief
pharmafile | February 19, 2010 | News story | Manufacturing and Production | AMPAC Fine Chemicals, Avrio, Haupt Pharma, NeoStem
German contract manufacturing organisation (CMO) Haupt Pharma said its site in Latina, Italy, has passed an FDA inspection. Following the seven-day audit, the site is now approved to produce two sterile penicillin antibiotics for the US market. The pre-approval inspection at Latina was triggered by the submission of two applications for sterile penicillin products by one of Haupt’s customers. The CMO says it is now able to deliver to the US market from five FDA-inspected sites in Italy and Germany.
US company AMPAC Fine Chemicals is planning to expand its business in Japan through an alliance with local company Inabata & Co of Japan. Inabata will acts as AMPAC’s exclusive agent in Japan for a range of technologies used to manufacture active pharmaceutical ingredients (APIs), including simulated moving bed separation (SMB) technology and expertise related to the production of high-potency ingredients, as well as its custom manufacturing services for small-molecule APIs.
Avrio Biopharmaceuticals, a subsidiary of US contract development and manufacturing company firm Irvine Pharmaceutical Services, has been granted California state approval to ship product from its recently-completed, 20,000 sq. ft. aseptic fill-and-finish facility. The plant boasts includes three
aseptic suites and five production suites, as well as laboratory space for quality control, microbiology, formulation, and a pilot production unit.
Stem cell specialist NeoStem has announced a public offering, expected to raise a little under $6 million, which will be used to build manufacturing and lab facilities in China and the USA. It will also help fund stem cell-related R&D and the licensing of new pharmaceutical products in China, said the firm in a statement.
Generics firm SOHM says a deal between its India manufacturing unit, SOHM India, and an unnamed pharma manufacturer in Himachal Pradesh, India, will double its production capability, reduce costs by 6%, and increase profitability. SOHM India will take up 100% of the manufacturing capacity of the company, along with its own capacity, and take over 85 products for sale in India and overseas.
Cork, Ireland-based company ProSys Sampling Systems has signed a $1 million contract with what it says is one of the world’s leading pharmaceutical companies for the design and manufacture of high containment isolators. High containment isolators aid in the handling of highly active and/or toxic chemicals ensuring the non-contamination of elements throughout the product research and development lifecycle, while enabling both manual and automatic handling procedures to be carried out with minimal operator exposure.
Sinovac Biotech, a China-based vaccine manufacturer, has invested $18 million in the purchase of buildings and land in Beijing that will house two new production lines to manufacture its EV71 hand, foot, and mouth disease vaccine and flu vaccines with an annual production capacity of approximately 30 million doses, as well as a filling and packaging line, a warehouse and an animal house.
US contract manufacturer Albemarle Corp has teamed up with organic chemistry specialist PharmaCore to provide manufacturing capabilities for customers with projects that require high-volume production. The alliance matches PharmaCore’s medicinal chemistry services and pilot-scale production with Albemarle’s large-scale manufacturing capacity.
