Almac invests $4m in biocatalysis R&D, describing such technologies as the way forward for the cost efficient production of highly chiral APIs and intermediates.
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.
The US FDA’s risk evaluation mitigation strategy (REMS) can be a challenge for pharmaceutical companies unfamiliar with the process according to PPD’s executive director of risk management Frank Gallo.
European contract manufacturing organisation (CMO) PharmaZell has increased capacity at its R&D centre in Vizag, India with a new cGMP Kilo-lab for API and drug intermediate production.
Stirling Pharma’s state-of-the-art Canadian plant will open its doors in late September, and first to come off the production line will be the drug, acetaminophen.
US drugmaker Merck & Co has announced plans to reacquire a Pennsylvania manufacturing plant to guarantee supply of key active pharmaceutical ingredient (API).
Prosonix has entered into an agreement with Trimel Biopharma, in which both companies will combine their respective technologies to deliver improved inhalation performance for respiratory medicines.
Sagent Pharmaceuticals’ heparin sodium injection, USP, which uses packaging and labelling safety features, has been approved by the US Food and Drug Administration (FDA).
Contract research organisation (CRO) Diteba Research Labs says partnership with fellow Canadian-based Thesis Chemistry reflects increasing customer demand for API and intermediate synthesis.
The DCGI has banned import of raw materials from 10 Chinese companies which lacked mandatory manufacturing standards, according to The Economic Times of India.
The Consortium for the Advancement of Patient Safety (CAPS) says research shows that USP plans to restrict printing on pharmaceutical vial ferrules and caps are “ambiguous and vague.”
American chemicals maker Cambrex has announced its active pharmaceutical ingredient (API) manufacturing facility has completed a successful FDA inspection.
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.
The Office of the United States Trade Representative (USTR) has expressed particular concern about the proliferation of counterfeit drugs in countries including Brazil, China, India, Indonesia and Russia.
US drug packaging firm Comar says acquisition of Universal Container Corp (Unicon) provides capacity for growth, particularly in key liquid medication delivery device market.
Syntagon is implementing a strategic pricing initiative to give “substantial cost savings” to pharma and biotech companies taking compounds into Phase I and II clinical trials.
in-PharmaTechnologist presents exclusive interactive maps of pharma manufacturing facilities in India, detailing the number of bulk drug and formulation facilities in each region of the country.
The US Food and Drug Administration (FDA) has issued Apotex with another warning letter about cGMP violations at two plants explaining the firm’s response to previous warnings “is inadequate and lacks sufficient corrective actions.”
Hong Kong, China-based drug wholesaler Julius Chen & Co has been ordered to recall 300mg/tablet formulation of a gout treatment name Puricos (allopurinol) after DoH officials discovered the firm packaged it without a license to do so.
A joint enforcement operation in the US has led to the arrests of two people accused of being involved in supplying counterfeit weight loss medication, including GSK’s Alli (orlistat).
Contract manufacturing organization (CMO) ScinoPharm says strong anticancer API sales and growing demand in Europe and Asia were key to record performance in 2009.
CEO Steffen Mittwich updates in-PharmaTechnologist on Atacama Labs' pneumatic dry granulation (PDG) API processing tech, its deal with German CMO Excella and future development plans.
A significant share of contract API maker ScinoPharm Taiwan is set to change hands after Watson Pharmaceuticals decided to sell its stake to Uni-President Enterprises Corporation.
The FDA has issued Eli Lilly with a warning letter detailing a significant deviation from cGMP at its API production facility in Puerto Rico, which makes ingredients used in Humalog (insulin lispro), a diabetes treatment.
Capsugel says latest addition to its Xcelodose range, Xcelolab, provides a rapid and reproducible solution for dispensing small amounts of pharmaceutical powders during laboratory stage drug development.
The US FDA says its new screening system will expedite the importation of genuine drugs and help inspectors focus their efforts on “high risk” products.
Schott AG has launched its InJentle syringe to improve the stability of highly sensitive drugs, which is a “major topic” for the company’s clients, according to a company director.
In-PharmaTechnologist presents a round up of recent developments in the field of drug delivery, with new deals for Starpharma and Penwest, and a regulatory filing for Hovione.
Indian drugmaker Lupin can start seeking US approval for new drugs made at its API plant in Mandideep, Bhopal after resolving the cGMP deficiencies that earned the facility a US FDA warning last year.
Cambridge Consultants (CC) says experience developing auto-injector technologies was critical to its contract appraisal work during Consort Medical’s £16.8m (€11.5m) takeover of The Medical House (TMH).
Daiichi-Sankyo subsidiary Luitpold Pharmaceuticals has acquired PharmaForce, giving it a 40,000 sq ft cGMP compliant sterile manufacturing facility and a 20,000 sq ft API production plant.
The Indian pharmaceutical market was worth $10.8bn (€7.5bn) this year and will more than double in value by 2014 according to a new industry report by Cygnus Business Consulting & Research.
The USP has clarified its proposed revision to the labelling of injectable drug vials which states that ferrules and cap overseals can only have markings intended to prevent an imminent life-threatening situation.
Lonza is manufacturing GlaxoSmithKline’s (GSK) and Genmab’s antibody Arzerra (ofatumumab), which was recently approved by the FDA, under a long-term supply deal.
Regulatory enforcement efforts to tackle counterfeit and substandard APIs are in disarray, according to Guy Villax, CEO of Hovione, who spoke at AAPS about the scale of the problem.
Abraxis Health has dedicated its manufacturing facility in Phoenix, Arizona, US which is the result of a $70m (€47m) investment to give the company the nanotech and biologics capacity needed for Abraxane production.
