Breaking News on Global Pharmaceutical Technology & Manufacturing

News in brief

Counterfeit antimalarials found in Ghanaian hospitals

09-Nov-2010 - Substandard and counterfeit antimalarials have been found in Ghanaian hospitals by the Medicines Quality Monitoring programme, a collaborative initiative involving the USP.

Overseas offices will shorten inspection times during crises

04-Nov-2010 - Overseas offices will help the FDA schedule inspections more quickly in times of crisis but, as yet, employees based abroad have visited relatively few facilities.

ATMI acquires Artelis in ‘disposables’ deal

04-Nov-2010 - ATMI has acquired Artelis, a Belgian biotech firm, in an effort to “get closer to customers” by widening its disposable technology portfolio to the life sciences research and manufacturing sector.

Visualisation of FDA overseas inspections by year & type

03-Nov-2010 - in-PharmaTechnologist presents interactive charts visualising FDA overseas inspections by type and year, as well as the proportion of sites that may never have been inspected.

Agilent opens new LCMS plant in Singapore

02-Nov-2010 - Agilent Technologies has opened a new instrument plant in Singapore to boost capacity for LC/MS production and drive expansion across Asia.

FDA may never have inspected 88 per cent of Chinese sites

27-Oct-2010 - The FDA may never have inspected 88 per cent of the 920 Chinese facilities in its inventory, according to the GAO.

Exclusive interview

Rx-360 membership to “snowball” as it prioritises growth

26-Oct-2010 - Rx-360 expects membership numbers to “snowball” in the coming year as it looks to build on progress made in establishing the consortium.

USP and MENA government labs form Network to better drug quality

25-Oct-2010 - The United States Pharmacopeial Convention (USP) and six government drug control laboratories in the Middle East and Northern Africa (MENA) join to launch a drug quality improvement Network.

Sanyo adds cost-effective GMP cell processing unit

25-Oct-2010 - Sanyo Biomedical is launching a cost-effective, space-saving stand-alone cell processing work station (CPWS) for GMP production.

Reaxa spin-off ADC Biotechnology talks new processing tech

21-Oct-2010 - A developmental purification system for Antibody-Drug-Conjugates will be launched by ADC Biotechnology (ADBC), a spin off from Reaxa, which promises reduced manufacturing costs for “magic bullet” cancer drugs.

WHO begins prequalification programme for selected APIs

21-Oct-2010 - The WHO is today initiating a pilot prequalification programme for selected APIs used in drugs for HIV and related diseases, antimalarials and anti-tuberculosis medications.

News in brief

New industrial CPO grade launched to meet drug sector demand

21-Oct-2010 - Bio-Research Products (BRP) launches lower cost, industrial chloroperoxidase (CPO) for organic syntheses in pharmaceutical manufacturing.

FDA cGMP warning letters round up

20-Oct-2010 - in-PharmaTechnologist presents a round up of cGMP related warning letters issued by the FDA this week.

J&J’s musty-smelling Tylenol is recalled again

20-Oct-2010 - Johnson & Johnson (J&J) recalls another 128,000 bottles of its over-the-counter painkiller, Tylenol, after new complaints of a “mouldy odour.”

News in brief

WR Grace’s acquisition of Synthetech approved by US Bankruptcy Court

19-Oct-2010 - Industrial catalysis firm WR Grace has been OKed to acquire fine chemicals group Synthetech by the US Bankruptcy Court.

Respiratory drugs a particular* opportunity for processing tech says Prosonix

19-Oct-2010 - Prosonix expects high demand for innovative particle processing technologies in the $24bn (€17bn) a-year respiratory pharmaceuticals market over the next few years.

News in brief

Baxter merges delivery tech and renal units

14-Oct-2010 - Baxter International will combine its delivery business, which supplies IV infusion systems and intravenous solutions, with its renal products unit in new Medical products division.

FDA & WHO collaborate on surveillance of counterfeit drugs

14-Oct-2010 - The FDA is to collaborate with the WHO to build a global surveillance and monitoring system for combating falsified medicines and breaches of the supply chain.

Pharmatek ‘roll’ out new equipment to expand GMP manufacturing capabilities

13-Oct-2010 - Pharmatek Laboratories has once again expanded service offerings at its San Diego, California facility by adding two roller compactors to its solid oral dosage form manufacturing capabilities.

European Centre for Chirality to open in December

13-Oct-2010 - New ‘chiral center’ in Belgium promises to help drug firms comply with regulatory demands for quality and accelerate registration of new compounds.

News in brief

Shipping pallets are likely source of Pfizer’s malodorous Lipitor, says Rexam

13-Oct-2010 - “Musty smells” associated with three Lipitor bottles indicate a problem within the supply chain, says Rexam of Las Piedras, Puerto Rico, who were confirmed by Pfizer as the “third-party recalling supplier.”

Exclusive interview

Falsified APIs and gangsters in the pharma industry

12-Oct-2010 - Guy Villax, board member of the EFCG, talks falsified APIs, EU efforts to tackle the issue, and the presence of gangsters in the pharma industry in an in-PharmaTechnologist video interview.

“Musty odour” caused Pfizer to recall 191,000 bottles of Lipitor

11-Oct-2010 - Pfizer says low levels of 2,4,6 tribromoanisole were detected in seven lots of the cholesterol buster, Lipitor, that it recalled in August.

News in brief

Gilead warned by FDA on US manufacturing plant

05-Oct-2010 - Gilead Sciences has received a warning letter from the US Food and Drug Administration (FDA) concerning manufacturing problems at the San Dimas, California, plant, where HIV medicines are made.

SP Scientific using Praxair tech to control lyophilisation

30-Sep-2010 - SP Scientific is combining its lyophilisation equipment with ControLyo from Praxair to enable precise control over the freeze-drying process.