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Headlines > February 2013

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Always Money for Good Ideas says Drug Delivery Pioneer

28-Feb-2013 - Good ideas in drug delivery will continue to attract investment though the increasing cost of clinical trials does pose a difficulty according to MIT Professor Robert Langer.

FDA Cites API Manufacturer for Stability, Purification Violations

28-Feb-2013 - The US FDA has warned API manufacturer Abbey Color about its inadequate stability program and unreliable water purification system, both of which were cited as earlier violations.

BIO, PhRMA Blast FDA Draft Guidance on E-Subs for Trial Site Data

28-Feb-2013 - Industry groups BIO and PhRMA are airing their discontents about US FDA draft guidance that could force sponsors to submit redundant clinical datasets for each trial site and waste time...

South Africa & Lonza Venture Hits Delay on API Facility Construction

27-Feb-2013 - A South African and Lonza joint project says issues in funding, competitiveness and green technologies have delayed construction of its API plant.

Cash Injection to 'Glide' the way for Solid Dose Injectors

27-Feb-2013 - Glide Pharma says it is working to bring its Solid Dose Injector (SDI) to market in the next 2-3 years.

Raman Spectroscopic Device in Fight Against Counterfeit Drugs

27-Feb-2013 - As an FDA commissioned report on counterfeit drugs is released the potential to detect them may lie in a handheld API analyzing device.

Albemarle Expands Manufacturing Capacity in Pennsylvania

27-Feb-2013 - Albemarle is adding new capacity at its manufacturing facility in Pennsylvania with a $30 million expansion.

Drug Shortages, Lost Business Chief among Concerns on EU API Import Deadline

26-Feb-2013 - US API manufacturers are getting increasingly worried about the looming July 2 deadline to come into compliance with the EU’s new requirements for written GMP certification. 

Oral Dose Competition Intensifies as Qualicaps Expands Manufacturing

26-Feb-2013 - Following a bout of investments, the oral dose solution market has been described as “competitive” and “dynamic” by two of the major players.

SHL: Auto Injectors Drive Further Expansion at Taiwan Plant

25-Feb-2013 - SHL says the prevalence of injectable drugs will drive auto injectors as it ramps up its Taiwanese production plant.

Pantarhei Sells Stake in Oral Contraceptive JV

25-Feb-2013 - Pantarhei Bioscience has sold in Estetra, its oral contraceptive development JV, to partner Uteron Pharma and will use the proceeds to fund further development.

GOED: Pharma is important for omega-3 but growing slowly

25-Feb-2013 - Pharmaceutical omega-3 products are important but will grow more slowly than some expect because of the long timeframe for drug approval, says the chief of the Global Organisation for EPA...

West: Proprietary Products Propped by Packaging and Manufacturing

25-Feb-2013 - West Pharmaceuticals says it is still intent on shifting to proprietary products following results from its packaging and contract manufacturing businesses.

FDA: Risk-based Immunogenicity Testing will Boost Protein Development

25-Feb-2013 - The US FDA says draft guidelines on risk-based immunogenicity testing of protein drugs will encourage the pharma industry to continue development efforts.

People on the Move: Jobs in Pharma

25-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.

BASF says Bend Accord Targets Different Chemistries than Dow deal

25-Feb-2013 - Bend Research has partnered with its second chemistry major in six months, teaming up with BASF to develop bioavailability-boosting excipients.

Cost Increases Likely for API Distributors in Europe Under New GDP Proposals

21-Feb-2013 - European API distributors may see costs increase if guidelines requiring quality systems and ‘management representatives’ at distribution points are adopted.

Capsugel Launches New Oral Formulation Business Unit

21-Feb-2013 - Capsugel says it will focus on lipid-based formulations as it launches a new Dosage Form Solutions Business Unit.

Collaboration With Britest Already Paying Off Says Aesica

21-Feb-2013 - UK CMO Aesica claims its partnership with process innovation group Britest has already increased capacity without capital investment. 

Dispatches from Informex

Updated IPEC Guide Steers Excipient Manufacturers Away From Unnecessary Tests

21-Feb-2013 - Excipient firms that skip lot testing or use alternative analysis methods should justify their decisions according to a new COA guide issued by IPEC Americas. 

IMCD Buys Indian Distributor Indchem for Pharma business

20-Feb-2013 - Chemical distributor IMCD Group says acquisition of Mumbai-based Indchem will build its presence in the Indian pharmaceutical excipient sector.

Dispatches from Informex

Intermediate CMOs Shift Attention to Nucleoside Development

20-Feb-2013 - CMOs (contract manufacturing organizations) developing pharmaceutical intermediates have shifted their focus to complex nucleosides, peptides and carbohydrates over the last five years, an expert says.

DSM says generics-focused partnering will drive pharma growth

20-Feb-2013 - Royal DSM expects its pharma unit to perform better in 2013 driven by a generics and end-of-lifecycle drug-focused partnership strategy. 

ATMI: Single Use Bioreactors on the Up, but US Tails Europe

20-Feb-2013 - New innovations in single-use bioprocessing systems are being picked up quicker in Europe than in the US, according to ATMI.

Unichem Sell Indian Formulation Plant to Mylan

19-Feb-2013 - Mylan Laboratories has purchased a new finished formulations facility in an Indian Special Economic Zone from Unichem Laboratories.

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