Inspections in countries not expected to confirm API quality or seek exemption from new EU import regs “cannot be seen as a solution” to shortage concerns says the MHRA.
Regulators in Non-EU countries can use results of previous inspections of API plants by EU or equivalent authorities in written confirmations, according to the European Commission.
The EC plan to extend drug GMP guidelines to APIs has met with a mixed response from industry groups, drugmakers and API manufacturers with some - like DSM and CEFIC – asking for clarification on the future of EudraLex Volume 4 Part II.
Scientists have uncovered a new simple way to “clean” genotoxic impurities (GTIs) in drug ingredients by mixing the solution with contamination-eating scavengers.
BASF has raised its prices for three ethanolamines (EOA), key intermediates in the production of a wide range of active pharmaceutical ingredients (API).
The US Pharmacopeial Convention (USP) has expanded its quality testing laboratory in Hyderabad in an effort to further strengthen ties with Indian drugmakers and regulators.
Suven Life Sciences’ facility in Pashamylaram, India has been cleared for the production active pharmaceutical ingredients (APIs) and intermediates by the US FDA.
The European Medicines Agency (EMA) has highlighted the quality APIs manufactured outside the EU as an area of concern in the draft 2015 road map it unveiled this week.
ShangPharma has raised $87m through an IPO on the New York Stock Exchange according to a Bloomberg report, beating the $46m to $53m the Chinese CRO forecast.
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).
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including Cel-Sci strengthening its manufacturing team and three promotions at Adolor.
Pharmatek has enhanced its preclinical and early stage clinical GMP supply capabilities by installing Capsugel’s Xcelodose system, becoming the first CDMO on the West Coast, US to have the equipment.
News of Bayer’s selection of ex-Thermo Fisher Scientific boss Marijn Dekkers as its CEO was somewhat overshadowed by a new FDA warning letter about quality testing at its manufacturing facility in Bergkamen, Germany.
Neuland Laboratories is building a facility to produce HPAPIs, which it predicts will contribute 20 per cent of its bottom line over the next two to three years, and has begun commercial peptide manufacture.
Particle Sciences (PSI) is aiming to advance its contract processing offering by collaborating with Microfluidics and sharing formulation and nanotechnology expertise.
Neuland has posted a 35 per cent growth in operating profits in its 2008 financial year, despite the pricing pressures and economic environment that have affected the industry.
Falling API sales and “an unprecedented negative economic environment” have forced Perrigo to cut its fiscal 2009 profit forecast and sent stock plummeting by 20 per cent.
India’s reputation as a base for quality, low-cost drug manufacture has proved irresistible for yet another big pharma company with Japan’s Eisai unveiling plans for a new production and R&D facility.
Codexis and Arch Pharmalabs’ expanded supply and development deal will see the latter produce APIs used in the manufacture of atorvastatin, principal component of Pfizer’s cholesterol buster Lipitor.
Ranbaxy’s CEO has confidently asserted that the US Food and Drug Administration’s (FDA) court action will be dropped in the near future and fired another warning shot at the “negative elements” he believes were behind the controversy.
Slovenian drugmaker Krka has paid just under $1.6m (€1m) for 7.5
per cent stakes in two Chinese drug and chemicals firms, namely
Zhejiang Menovo Pharmaceuticals and Anhui Menovo Pharmaceuticals.
The first steps in tightening the safety controls on the
pharmaceutical ingredients imported to the US from China have been
taken following months of negotiations between the regulatory
bodies of the two countries.
French pharma company Servier has announced the launch of a new
manufacturing facility and also the expansion of its existing
operation in Ireland, an investment totalling €184m.
Service provider Saltigo is reinforcing its position in the
stabilising fine chemical custom manufacturing industry by
investing in the expansion of its German facility.
Organon, Akzo Nobel's healthcare division, has conceded it will
have to close its Diosynth manufacturing plant in Scotland by the
end of the year since it cannot divest it, as the unit's lack of
competitiveness in the production...
US firm Codexis and Shasun Chemicals and Drugs of India have signed
a manufacturing and supply agreement for a pharmaceutical
intermediate for a generic drug.
Germany's Girindus is this year's recipient of the Product
Differentiation Award sponsored by consulting firm Frost &
Sullivan for its innovative developments in the commercial
production of oligonucleotides.
The restructuring activity that has features this year in the
European pharmachem industry continued yesterday with the news that
Germany's Merck KGaA had sold off BioMer, a joint venture focusing
on orthopaedic products.
