DSM to sell APIs made by Indoco Remedies

31-Jan-2012 - DSM Pharmaceutical Products (DPP) will sell APIs made by Indian manufacturer Indoco Remedies in a new agreement that fits with its global expansion plan.

Dishman considers future of Chinese API plant

31-Jan-2012 - Ingredient maker Dishman Pharmaceuticals has confirmed that it may offload its Chinese API (active pharmaceutical ingredients) factory.

Novartis hit with another 483 after FDA finds repeat failings

31-Jan-2012 - The FDA has hit Novartis with another 483 after finding seven repeat observations and a backlog of 1,360 overdue consumer complaints.

update 2

BASF hikes EOA prices days after asking EU to review US import levies

30-Jan-2012 - BASF has hiked its prices for ethanolamines just days after asking the European Commission to review measures designed to stop US exporters selling the compound at less than cost to...

Patheon boosts solubility enhancing tech offering, says expect more to come

30-Jan-2012 - Patheon will focus its upcoming growth efforts on solubility enhancing tech after receiving an influx of requests from clients.

FDA updates Q&A to cut topical antiseptic contamination

30-Jan-2012 - The FDA has updated its question and answer document to help manufacturers of topical antiseptics prevent contamination.

Zogenix joins with Battelle to out-licence drug delivery tech

30-Jan-2012 - Zogenix is collaborating with Battelle to out-license its needle-free drug delivery technology, DosePro.

Danone and Mead Johnson to make united Pfizer nutrition bid?

27-Jan-2012 - Danone and Mead Johnson may make a joint bid for the €8bn infant nutrition-dominated Pfizer nutrition business that is up for sale, according to press reports.

Manufacturing issues round-up

26-Jan-2012 - in-PharmaTechnologist presents a round-up of issues within the pharmaceutical manufacturing industry, including Novartis’ plans to restart Nebraska ops and problems for Roche at it’s South Carolina facility.

US hits Ranbaxy with injunction to boost manufacturing quality

26-Jan-2012 - The US has filed a “groundbreaking” injunction against Ranbaxy to force the generic giant to make “fundamental changes” at its plants.

Simplifying taxes would encourage Pharma manufacturing in France, says govt advisory board

26-Jan-2012 - Simplification of French tax laws would incentivise Pharmas to manufacture drugs in the country according to a government advisory body.

EU could make API suppliers verify starting material sources

26-Jan-2012 - Europe is considering forcing API manufacturers to verify the source of starting materials as part of GMP revisions.

UPDATE

Manufacturing round-up: new facilities in India

25-Jan-2012 - in-PharmaTechnologist presents its round-up of the latest manufacturing headlines including new facilities for Aptar and Granules, and some good news for Swiss Novartis workers.

Albermarle cites favourable pricing and pharma sales as factor in Q4 rev growth

25-Jan-2012 - Ibuprofen API maker Albemarle says favourable volumes and pricing helped drive gains made by fine chemicals unit in Q4.

Ashland investing in capacity, raising prices in ISP integration

25-Jan-2012 - Ashland is investing in production assets and raising prices as it looks to get the most from its $3.2bn acquisition.

Granules says Big Pharma demand drove gains in Q3

24-Jan-2012 - Granules India says Big Pharma demand for highly efficient manufacturing in era of patent loss helped it gain market share in Q3 fiscal 2012.

FDA & EMA plant approvals to cut bottlenecks at Genzyme

24-Jan-2012 - The FDA has followed the EMA in approving the Framingham, MA plant that Genzyme hopes will cut production bottlenecks.

SSB teams with Refine Technology to improve connectivity in biomanufacturing

24-Jan-2012 - Sartorius Stedim Biotech (SSB) says its partnership with Refine Technology will help meet demand for greater connectivity between retention devices and bioreactors and save Pharmas time and money

Alnylam cutting headcount to focus cash on RNAi projects

23-Jan-2012 - Alnylam is cutting its headcount by one-third to lower operating costs as it attempts to bring an RNAi product to market.

EMA revises active substance guidelines to streamline regs

23-Jan-2012 - The EMA has revised guidelines on active substance master files (ASMF) to stop multiple EU nations assessing the same documents.

Pharmacy aseptic failings likely cause of vision loss; researchers

23-Jan-2012 - Poor aseptic technique at compounding pharmacies is the most likely cause of Avastin-related vision loss, researchers claim.

SGS to open 2nd Indian lab on schedule; 2011 revs grow despite ‘tough’ European market

19-Jan-2012 - SGS’ new analytical lab in Mumbai, India will open later this week just six months after the analytical services firm began its construction .

NovaDel seeks sale to save it from bankruptcy protection

19-Jan-2012 - Drug delivery firm NovaDel has warned it lacks the cash to continue beyond this month and may file for bankruptcy protection.

FDA publishes QbD example to help generics firms file ANDAs

19-Jan-2012 - The FDA has published a QbD approach to modified release tablet development to help generic companies meet its 2013 deadline.

Air can be used as barrier for controlled drug release, say scientists

18-Jan-2012 - A new study has found a way to use air as a barrier for controlled drug release.

News in brief

Takeda will cut 2,800 jobs to integrate Nycomed

18-Jan-2012 - Takeda has announced it will cut 2,800 jobs by 2015 as part of its integration of Nycomed.

German firms partner to bring biocatalysis to fine chemicals

18-Jan-2012 - Enzymicals and Herbrand PharmaChemicals have partnered to incorporate biocatalytic processes into fine chemical manufacturing.

Sigma-Aldrich looks to HPAPIs as generic sector heats up

18-Jan-2012 - Sigma-Aldrich is prioritising HPAPIs as it seeks to grow its custom pharma business in the face of low-cost competition.

News in brief

GSK switches MENA HQ from Dubai to Turkey

17-Jan-2012 - Pharma giant GlaxoSmithKline (GSK) has moved its offices in charge of the Middle East and North African (MENA) market to Istanbul, Turkey.

Excipact scheme to launch next week

17-Jan-2012 - Excipient makers could save up to 200 man hours with a new industry-driven, third-party audit certification scheme set to launch next week.

PIC/S adds GDP to remit to tackle supply chain threats

17-Jan-2012 - PIC/S has strengthened promotion of global GDP harmonisation and confidentiality in a revision to its documentation.

FDA plans to boost oversight using foreign regulators’ info

17-Jan-2012 - The US FDA plans to study foreign regulators’ GMP inspection reports with a view to using them to support its enforcement efforts.

UPDATE

New RNA delivery platform could improve aptamer internalisation, say researchers

16-Jan-2012 - A new discovery platform for RNA delivery vehicles could mean 20 per cent more efficiency for guiding nanoparticles into cancer cells, say researchers.

FDA plans overseas inspections as GDUFA goes to Congress

16-Jan-2012 - The US FDA has sent its generic user fee recommendations to Congress ahead of a meeting to discuss the plan next month.

Novartis to cut US jobs on Rasilez Ph III failure and Diovan patent loss

16-Jan-2012 - Swiss drug major Novartis has announced plans to cut US jobs and predicts a challenging couple of years for its pharma division.

China wants vaccine production innovation to boost local sector

16-Jan-2012 - The Chinese government is encouraging development of new vaccine production processes in a bid to achieve self-reliance.

News in brief

Clinigen inks antiretroviral API production pact with PCAS

12-Jan-2012 - Clinigen and PCAS have inked a long term supply pact for the production of the API for Foscavir.

US team develops H-heterocyles production method with implications for Pharma

12-Jan-2012 - US scientists say a new N-heterocycles synthesis method could open door to the production of novel antibiotics, cancer and pain drugs.

Injectables maker NantWorks will give Pfizer's old Indiana facility an $85.5m makeover

12-Jan-2012 - NantWorks has unveiled plans to pump $85.5m into a new oncology and critical care injectables manufacturing plant in Terre Haute, Indiana.

Lack of tax transparency in '10 may put pharma off Puerto Rico

12-Jan-2012 - The lack of transparency when Puerto Rico imposed a new tax in 2010 may deter drugmakers from expanding on the island, a report found.

Ashland to boost disintegrant capacity at Texas plant

11-Jan-2012 - Ashland says it will ramp up production of the tablet disintegrant and dissolution aid polyvinylpyrrolidone (PVPP) to meet growing drug industry demand.

Collaboration needed to reverse supply chain “neglect”; expert

11-Jan-2012 - Greater collaboration between regulators, suppliers and manufacturers is needed to reverse decades of supply chain neglect, an expert said.

News in brief

Sanofi to make $170m cuts in operational costs

11-Jan-2012 - Sanofi announced it will cut $170m of its operational costs this year as it plans to ramp-up acquisitions spending to $2.6bn.

Bumpy road ahead for Hospira but issues “fixable”, CEO says

11-Jan-2012 - Hospira will uncover more issues as it gets to the root cause of its quality troubles but the situation is “very fixable”, its CEO said.

MonoSol and Midatech form new nanoparticle-film delivery tech JV

10-Jan-2012 - Delivery tech firm MonoSol Rx and nanoparticle excipient developer Midatech have set up a new diabetes-focused joint venture (JV).

Zhongxi Sunve buys stake in Chinese oncology API business

10-Jan-2012 - Zhongxi Sunve has bought a stake in a Chinese oncology API manufacturer and has further takeovers in the pipeline.

Xoma cuts manufacturing costs to ramp-up R&D

10-Jan-2012 - Xoma will further reduce its manufacturing capacity with plans to cut a third of its workforce.

US fake drug seizures up 200%

10-Jan-2012 - The value of counterfeit pharmaceuticals seized at US borders jumped 200 per cent in 2011 as enforcement actions took effect.

Research needed on drug residues in water says Recipharm award winner

09-Jan-2012 - Further analysis is needed to assess the risk posed by low level pharmaceutical contamination of water supplies says the winner of Recipharm’s 2011 environmental award.

News in brief

India to inspect six China manufacturers following GMP complaints

09-Jan-2012 - Chinese companies exporting drugs in bulk will come under the microscope next month when the Indian government sends a team of officials to inspect manufacturing plants.

Novartis to take $120m charge to fix US plant, recall OTC drugs

09-Jan-2012 - Novartis expects to take a $120m charge to improve a US manufacturing plant and recall drugs after the FDA sent it a 483.

Rousselot buys Eastman Gelatine Corp in bid for pharma growth

09-Jan-2012 - Rousselot says its acquisition of Eastman Kodak’s Gel Corporation will boost its gelatine production capacity and help it meet soaring drug industry demand.

USP publishes draft supply chain integrity chapter

09-Jan-2012 - The USP has published draft supply chain integrity guidance outlining steps to stop counterfeit or adulterated drugs reaching patients.

Accelrys moves into Pharma QA/QC with VelQuest acquisition

05-Jan-2012 - R&D software firm Accelrys says it will speed up the pharma QA/QC process and reduce the compliance risk ten-fold through its $35m takeover of VelQuest.

US FDA's 2011 guidance documents round-up

05-Jan-2012 - The US Food and Drug Administration (FDA) will soon start asking drugmakers to play a greater role in guideline development . Before that process begins in-Pharmatechnologist.com takes a look at the...

Julphar to become first Middle Eastern insulin maker

05-Jan-2012 - Gulf Pharmaceutical Industries is set to become the first insulin maker in the Middle East with its new $136m plant in Ras Al Khaimah, UAE.

British Empire gong for GSK’s Witty

04-Jan-2012 - GSK CEO Andrew Witty has been knighted in the Queen's New Year Honours list in recognition of his services to the UK economy and pharmaceutical industry.

Rx-360 warns Pharmas of guar gum shortage

04-Jan-2012 - Supply chain security group Rx-360 has warned that guar gum – a thickening agent that is widely used in the drug industry – is in short supply.

FDA group calls for industry to submit draft guidance docs

04-Jan-2012 - The FDA should encourage industry to submit draft guidance to speed regulatory development, an agency working group found.

India faces intense competition in pursuit of $25bn export goal

04-Jan-2012 - The Indian pharmaceutical industry faces “intense competition” from China as it tries to grow exports to $25bn, the country's commerce minister said.

EC discusses ‘equivalence assessments’ for APIs shipped to EU

03-Jan-2012 - The European Commission (EC) has set out its plans for ‘equivalence assessments’ for manufacturers in countries seeking to export APIs to Europe.

BASF says new film tech makes API degradation concerns a thing of the past

02-Jan-2012 - BASF’s new multi-functional plastic film will raise the bar for purity levels in synthetic excipients, says the firm.

India posts draft guidance on stability data for clinical trials

02-Jan-2012 - India has released draft guidance on stability data needed to support approval of Phase I to III clinical trials.