Bulk ingredients

US FDA poised to up China inspections after favourable FY14 budget

20-Jan-2014 By Gareth Macdonald

The US FDA is positioned to increase drug plant inspections in China after US President Barack Obama signed a $1.1tr (€881bn) budget for fiscal 2014 into law on Saturday.

Lonza to produce API for Pharmacyclics oral cancer drug

14-Jan-2014 By Dan Stanton

Lonza has extended a contract to manufacture the API for Pharmacyclics’ oncology drug Imbruvica following its recent regulatory approval.

The economic pain in Spain not slowing CMO gains says IDIFarma

13-Jan-2014

Current economic problems may have hit Spanish drugmakers hard, but the downturn has not dampened demand for contract manufacturing services according to IDIFarma.

Catalent to make Levodopa-Induced Dyskinesia for Ph III trials

08-Jan-2014

Catalent has been contracted to make supplies of an extended-release drug for Parkinson’s disease (PD) patients set to enter Phase III trials by developer Adamas Pharmaceuticals.

Patheon third largest CMO and top PDS provider, report says as DSM merger looms

08-Jan-2014 By Dan Stanton

Patheon is the world’s largest pharmaceutical development services (PDS) provider and third largest contract manufacturer, according to a report released yesterday.

Investment guru at Catalent owner Blackstone predicts Obamacare success

07-Jan-2014 By Gareth Macdonald

Obamacare will recover from its IT problems and thrive in 2014 according to a senior executive at the investment firm which owns Catalent.

Plan to lease Doxil space at Ben Venue to J&J needs approval says BI

06-Jan-2014 By Gareth Macdonald

Boehringer Ingelheim (BI) has warned that latest efforts to ensure continued Doxil production at Ben Venue's troubled sterile injectables plant in Bedford, Ohio must still be approved.

Recipharm to sell drug co-developed with Astimex, signs new manufacturing deal

18-Dec-2013

CMO Recipharm has set out to sell a new own-brand infectious disease medication it developed in partnership with fellow Sweden-based firm Astimex Pharma.

Elder to sell drugs to Torrent to cut debts and focus on CMO and OTC biz

16-Dec-2013 By Gareth Macdonald

Elder Pharmaceuticals has agreed to sell its branded drug portfolio to Torrent Pharmaceuticals in a deal that will refocus the firm as a CMO and anti-infectives producer. 

War, what is it good for? Emergent bids $222m for biodefense supplier Cangene

12-Dec-2013 By Gareth Macdonald

US Government anthrax vaccine contractor Emergent BioSolutions has announced plans to buy Cangene in its second biodefense-focused deal in a year.

Puerto Rico must address rising costs to ensure pharma future, says expert

10-Dec-2013 By Dan Stanton

Puerto Rico’s drug manufacturing industry has no future unless utility costs and taxes are controlled, according to a regulatory expert.

Brazil makes proposed outsourcing regulations available for comment

09-Dec-2013 By Gareth Macdonald

ANVISA has set out what it expects of contractors that provide manufacturing, quality control services and drug storage in the Federal Official Gazette of Brazil (DoU) and invited stakeholders to comment.

Hospira: In-house API production to reach 50% by 2018 through acquisitions

09-Dec-2013 By Dan Stanton

Hospira says it intends to up in-house manufacture of its APIs from 10 to 50% by 2018 as it awaits completion of last year’s acquisition of Orchid.

Jubilant hit with FDA warning letter at US plant earmarked for expansion

05-Dec-2013 By Gareth Macdonald

Jubilant Life Sciences has received a US FDA warning letter for its manufacturing plant in Spokane, Washington State.

update

Boehringer Ingelheim looking for Bedford Labs buyer

05-Dec-2013 By Gareth Macdonald

CMO Ben Venue Laboratories has asked Bank of America Merrill Lynch to try and find a buyer for its generic injectables business, Bedford Labs.

US FDA sued for alleged 'unlawful' detention of API batch destined for CMO

05-Dec-2013 By Gareth Macdonald

A lawsuit alleging that the US FDA unlawfully detained a batch of acetaminophen API destined for CMO Gemini Pharmaceuticals could have significant impact on the drug industry's definition of an ‘end user.' 

DSM's pharma products business wins allergy drug process dev contract

04-Dec-2013

Soon to be merged CMO DSM Pharmaceutical Products (DPP) has been contracted to provide process development for a protein allergy drug being developed by Tunitas Therapeutics.

Pfizer wants more biopharma CMO work and would manufacture for Big Pharma rivals

04-Dec-2013 By Gareth Macdonald

The climate for biomanufacturing has changed according to Pfizer, which has set out to win more contracting work for its hormone plant in Sweden and says it will even consider making large molecule drugs for Big Pharma rivals. 

APL says 'specials' biz benefits CMO offering

02-Dec-2013 By Gareth Macdonald

Apotek Produktion & Laboratorier AB (APL) says manufacturing knowledge and drug delivery tech knowhow gained by its compounding business is a boon for its CMO unit.

Catalent expands Kansas City plant for Pharmacyclics commercial contract

26-Nov-2013 By Dan Stanton

Catalent says it is creating dedicated space and possibly jobs at its Missouri facility in order to service a commercial contract for Pharmacyclics’ oncology drug Imbruvica.

On the road report

Kemwell CEO says environmental efforts are worth the cost

26-Nov-2013 By Gareth Macdonald

Kemwell CEO Agneta Bergvall says drugmakers' efforts to make pharmaceutical manufacturing green are worth the cost.

High energy costs hurting competitiveness say UK pharma and chem firms

21-Nov-2013 By Gareth Macdonald

The high cost of energy in the UK is having a negative impact on drug and chemical firms' ability to compete according to manufacturers quizzed by the Chemical Industries Association (CIA).

update

DSM plans to merge pharma business with Patheon

19-Nov-2013 By Gareth Macdonald

Royal DSM wants to merge its pharmaceutical products business with Patheon and has signed a deal with the latter's owner, investment group JLL Partners.

WuXi not worried by Big Pharma R&D spending cuts as manufacturing bolsters Q3

18-Nov-2013 By Dan Stanton

WuXi says diversifying its client base means it is not worried about big clients like Merck & Co. restructuring R&D as the firm reports a strong Q3.

Chemport confirms it will keep supplying Amarin with Vascepa API

06-Nov-2013 By Gareth Macdonald

A third Amarin supplier has confirmed it will continue to supply the firm with pharma-grade omega-3 despite a US FDA panel recommending against a label extension for the heart pill Vascepa.

update

DSM wants a partner that can grow its pharma business in Asia

05-Nov-2013 By Gareth Macdonald

DSM says it has not found the right partner for its pharmaceutical products business and is continuing to look for a collaborator with which it can grow in Asia.

Granules India to buy Auctus and says Singapore closure is a 'non-event'

04-Nov-2013 By Gareth Macdonald

Granules India has outlined plans to buy drug intermediate and API maker Auctus Pharma, set up an actives R&D site and announced its intention to wind up its ‘shell’ operation in Singapore.

US FDA gives green light for WuXi intermediate manufacturing

30-Oct-2013 By Dan Stanton

The US FDA has completed a pre-approval inspection at a Wuxi PharmaTech facility in order for the firm to manufacture a new intermediate for a client.

update

Novasep to keep supplying Amarin with Vascepa API

30-Oct-2013 By Gareth Macdonald

Novasep has confirmed it will keep supplying Amarin with omega-3 API as the US FDA withdraws special status afforded to Vascepa trial.

Dispatches from CPhI

Novasep granted US FDA approval at two EU API facilities

29-Oct-2013 By Dan Stanton

French CMO Novasep has received the thumbs up from US regulators at two of its European API manufacturing facilities.

Dispatches from CPhI

McKinsey consultants help to pull Patheon off the road to bankruptcy

23-Oct-2013 By Zachary Brennan

Patheon brought in McKinsey consultants over the last three years to help overhaul its sagging business and institute a number of simple process changes that resulted in deep transformations.

DPT fielding calls from Ben Venue customers

17-Oct-2013 By Gareth Macdonald

US contractor DPT says it has received calls from customers of soon-to-close CMO Ben Venue Labs.

Regulatory approval for CMC Biologics' upgraded Danish plant

16-Oct-2013 By Dan Stanton

CMC Biologics has received renewal of its GMP credentials from the Danish Medicines Agency (DKMA) after upgrading the manufacturing capacity at its Copenhagen site.

Evocatal moves to new HQ near Cologne

10-Oct-2013 By Gareth Macdonald

Lanxess backed enzyme and fine chemicals producer evocatal has moved to a new HQ, beefed up production capacity and is on the look out for new scientific staff.

Cambridge Major Labs and AAIPharma Merge

08-Oct-2013 By Dan Stanton

AAIPharma says the merger with Cambridge Major Laboratories (CML) will bring clients the benefits of integrated Chemistry and Manufacturing Controls (CMC) services from two high-growth CMOs.

Boehringer CMO Ben Venue Labs to close permanently, layoff 1,100

04-Oct-2013 By Zachary Brennan

Beleaguered sterile injectables manufacturer Ben Venue Laboratories has announced it will close permanently by the end of 2013 and lay off 1,100 employees in Ohio.

CMO hit with first ever US FDA warning letter for failing to pay facility fee

03-Oct-2013

Germany-based CMO CPM Contract Pharma was hit with the first US FDA warning letter for failing to self-identify its manufacturing facility and pay the facility fee required by the Generic Drug User Fee Amendments of 2012.

EC does not expect US FDA to reduce inspections during shutdown

01-Oct-2013 By Gareth Macdonald

The US Government shutdown is unlikely to reduce US Food and Drug Administration (FDA) inspection activity according to the European Commission.

More Ben Venue manufacturing issues will lead to Doxil shortages in October

30-Sep-2013 By Zachary Brennan

Continued manufacturing problems at CMO Ben Venue Laboratories will cause an interruption of supplies of the cancer treatment Doxil in mid-to-late October, Janssen said.

Recipharm Gets Regulatory Nod to Make and Package Abstral in Japan

23-Sep-2013 By Dan Stanton

Recipharm has received approval to manufacture and package the opioid drug Abstral for Kyowa Hakko Kirin in Japan.

Massachusetts CMO Completes FDA Inspection for Two APIs

23-Sep-2013

CMO PCI Synthesis recently completed its sixth US FDA inspection at its cGMP site in Newburyport, Massachusetts.

Catalent named as US Trokendi XR delivery tech supplier

23-Sep-2013 By Gareth Macdonald

Catalent Pharma Solutions has been named as the supplier of delayed-release technology for an epilepsy treatment launched by Supernus Pharmaceuticals in the US this month.

Aesica opens new plant for oral diabetes drug

19-Sep-2013

Aesica says its new high capacity manufacturing plant in the UK will ship diabetes treatment to markets worldwide.

More expansion at Cedarburg Hauser's WI API plant

18-Sep-2013

Cedarburg Hauser has ramped up production capacity at its API plant in Wisconsin, US citing customer demand.

Columbia Labs add Molecular Profiles CEO to board and plans contracting biz

17-Sep-2013

Recent entrant into the formulation services sector Columbia Laboratories has added Molecular Profiles execs to its board.

Aurobindo gives more info on injectables rejig and ingredient M&As

16-Sep-2013 By Gareth Macdonald

Aurobindo Pharma has given more details of a planned expansion of its API and antibiotics businesses and has confirmed its intention to rejig its injectables operations.

update

Scinopharm To Supply Supernus' with API For New US Epilepsy Drug

10-Sep-2013 By Gareth Macdonald

Scinopharm will supply Supernus Pharmaceuticals with the API topiramate in a contract announced this week.

Up to 30% of CMO to Exit Biz in Next 10 Years, Report Says

10-Sep-2013 By Dan Stanton

The CMO market remains highly fragmented with thirty percent of active players likely to exit the business in the next ten years, according to a Frost & Sullivan report.

Shasun Plant Gets Third Regulatory Thumbs Up in As Many Months

03-Sep-2013 By Gareth Macdonald

The UK MHRA has given Shansun Pharmaceutical’s drug formulation plant in Puducherry, India a clean bill of health after an inspection last month.

Expansion Preps Haupt for Bulk Contraceptive Pill Contract

29-Aug-2013 By Dan Stanton

Haupt says it will become Europe’s second largest manufacturer of contraceptive pills as it gets set for production after winning a contract from a “large group” in Ireland.