Parabolic Drugs will enter India’s CRAMS sector with new dedicated manufacturing facilities designed to attract “global innovator companies” enabling its business to grow in regulated markets.
Patheon has posted a 12 per cent growth in operating profit in the second quarter and said there is “strong evidence” the business environment is improving.
Water used by pharmaceutical manufacturing facilities is being released into the environment with drug concentrations that are up to 1000 times higher than normal according to a study conducted by the US Geological Survey (USGS).
Xcellerex is building a second cGMP FlexFactory biomanufacturing facility to support clients transitioning to their own plants and provide contract manufacturing services.
Massachusetts-based Pharmalucence is constructing a 70,000 sq ft production facility to boost the contract manufacturing capacity it can offer local biotechs.
American chemicals maker Cambrex has announced its active pharmaceutical ingredient (API) manufacturing facility has completed a successful FDA inspection.
X-ray transparency and added durability are benefits of a new conveyor belt that helps improve performance for contaminant detection in glass containers on food and pharmaceutical lines, said Mettler Toledo Safeline.
An anti-counterfeiting pilot project in Nigeria, which uses a mobile authentication service (MAS) to validate genuine medication, has completed a 100-day pilot phase. Preliminary results suggest the scheme is well on the way to becoming an effective defence...
The USP is strengthening links with Eastern Europe and Russia by agreeing to share quality standards with Ukraine and offering training courses in Moscow.
India-based Surya Pharmaceuticals is planning to raise Rs 500 crore ($100m) to fund construction of an active pharmaceutical ingredient (API) production plant, according to local media reports.
Indian-based drug makers continue to come under intense scrutiny by the US Food and Drug Administration (FDA) as the regulatory body issues warnings to healthcare professionals not to use certain brands of antibiotics due to potential contamination.
CMOs are set to gain biologics business and capacity in the coming years as large pharma increasingly outsources to cut costs and speed development, according to a report published today.
ISP Pharmaceuticals has expanded its extrusion spheronisation offering with the installation of new dedicated technology at its laboratory in Sao Paulo, Brazil.
Siegfried is to supply at least 60 per cent of Jazz Pharmaceutical’s global requirement for sodium oxybate, the active pharmaceutical ingredient (API) in Xyrem.
Claris has initiated a recall of three antibiotics it manufactures, which are also sold by Sagent, Pfizer and West-Ward, after the FDA warned of contamination.
Hungary-based Ubichem Research has gained approval to supply cGMP radiolabelled APIs in the European Union (EU), positioning it to benefit from increased demand.
DPT Laboratories has added bulk production and packaging capacity at its liquid and semi-solids plant in San Antonio, Texas in a continuation of its recent manufacturing reorganisation.
Indian’s Biocon will supply US biopharma Optimer Pharmaceuticals with the API fidaxmicin for its candidate Clostridium difficile infection (CDI) drug OPT-80 under a new long-term contract.
AMRI is reducing its US workforce 10 per cent and halting operations in one R&D lab at its facility in Rensselaer, New York as “softness” in the domestic market continues beyond its expectations.
US biotech Genzyme will pay $175m and cease some manufacturing operations at its facility in Allston, Massachusetts under final terms of Food and Drug Administration (FDA) consent decree.
The Indian Government plans to help medium sized pharmaceutical firms meet World Health Organisation (WHO) manufacturing plant standards with a new subsidy scheme.
US CMO Contract Pharmaceuticals (CPL) to close Buffalo plant by the end of 2011 on weak demand it attributes to pharmaceutical industry outsourcing cuts in downturn.
India and Thailand have requested the WHO ends its involvement with IMPACT, which the countries believe has conflicts of interest, and begin a programme focused on quality, safety and efficacy.
Johnson Matthey is to manufacture the active pharmaceutical ingredient (API) in KP201, a pain drug developed by KemPharm, as part of a risk-and-reward sharing partnership.
Concerns about the quality and capabilities of Baxter’s manufacturing operations have led to Halozyme issuing a notice of breach and stating it may terminate their Hylenex relationship.
Microfluidics has posted an operating income of $106,000 (€84,000) in its results, the third consecutive quarter of profit, and is looking to expand products and services to continue growth.
Beike Biotechnology has opened a stem cell storage and processing facility at the 20,000 sq m regenerative medicine base in China, furthering the nation’s development in the field.
DSM Biologics says successful XD tech expansion paves way for smaller bioreactors that lowers cost of production facilities and, ultimately, of bio-drug manufacture.
Albany Molecular Research (AMRI) says Q1 decline is due to “soft” demand for contract manufacturing services and trial materials, but is still confident of full-year growth.
DSM Biologics says combining its XD platform with newly-acquired Rhobust chromatography platform will create high yield, low cost bio-manufacturing option.
The WHO has called for recall and destruction of all batches of Indian drugmaker Shantha Biotechnics’ Shan5 vaccine after the discovery of “white sediment” in some vials.
CMO Goodwin Biotechnology Inc (GBI) is collaborating with Hyprocell to help clients that need manufacturing services but have a sub-optimal cell line producing low concentrations.
The US FDA says Teva Pharmaceutical Industries’ plan to fix cGMP violations observed at its plant in Irving, California “lack sufficient corrective actions.”