Excipients, raw materials & intermediates

Update

Ashland to Expand Delaware Formulation and Contract Manufacturing

11-Mar-2013 By Dan Stanton

Ashland says it is expanding its contract manufacturing business in order to offer its customers greater scope in drug solubilization.

EMA proposes virus testing for food sector-derived trypsin used in drugmaking

06-Mar-2013

Food industry controls do not ensure porcine trypsin is virus-free according to the EMA, which proposes testing procedures for drugmakers which use the reagent in a new consultation document.

update

SAFC Expands Manufacturing Capacity to Meet Growing EU Needs

05-Mar-2013 By Zachary Brennan

SAFC will expand manufacturing capacity at its facility in Irvine, Scotland, to include large-scale production of bulk dry powder media and reagents to save EU clients’ money in shipment costs.

Raman Spectroscopic Device in Fight Against Counterfeit Drugs

27-Feb-2013 By Dan Stanton

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

BASF says Bend Accord Targets Different Chemistries than Dow deal

25-Feb-2013 By Gareth Macdonald

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

Capsugel Launches New Oral Formulation Business Unit

21-Feb-2013 By Dan Stanton

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 By Gareth Macdonald

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

DSM says generics-focused partnering will drive pharma growth

20-Feb-2013 By Gareth Macdonald

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

IMCD Buys Indian Distributor Indchem for Pharma business

20-Feb-2013 By Gareth Macdonald

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 By Zachary Brennan

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.

IPEC Welcomes 'Long Awaited' EC Excipient Risk Assessment Plan

19-Feb-2013 By Gareth Macdonald

‘Long awaited’ draft guidelines on excipient risk assessments proposed by the European Commission (EC) have been welcomed by industry group IPEC Europe.

Dow Signs Up Cambrex for Bioavailability Partnership

19-Feb-2013 By Dan Stanton

Dow has contracted Cambrex to make its solubility enhancing polymer HPMCAS, adding manufacturing clout to its bioavailability-focused collaboration with Bend Research.

AMRI Deal a Catalyst for Pharma Growth says Codexis

14-Feb-2013 By Gareth Macdonald

AMRI has teamed up with biocatalysis firm Codexis to develop cheaper, faster and greener ways of manufacturing APIs.

FDA Reveals More Info on API File Submissions

13-Feb-2013 By Zachary Brennan

Drug Master File (DMF) completeness reviews required under GDUFA could take three months and should be sought before ANDA submission according to the US Food and Drug Administration (FDA).

Lonza rejigs ops and says more changes are to follow

05-Feb-2013 By Gareth Macdonald

Lonza has reorganised its operations into two new divisions – Pharma and Specialty ingredients – and says more changes are on the way.

Pfizer wants manufacturing 'efficiencies' in 2013

30-Jan-2013 By Gareth Macdonald

Pfizer's CEO has raised the possibility of more cost cutting in manufacturing operations in 2013 to offset the impact of patent loss for key products.

Granules optimistic after poor Q3: "PFI bottleneck will be unblocked"

29-Jan-2013 By Dan Stanton

Granules India says it expects to be back on track by 2014 following slow sales growth and depressed profitability margins.

XD cell culture technology: DSM boosted by Amgen license

17-Jan-2013 By Dan Stanton

DSM hints at high yield and cost-cutting benefits in licensing its cell growth technology to Amgen.

Mitsubishi to buy dominant HPMC capsule maker Qualicaps as gelatin shortages continue

03-Jan-2013 By Gareth Macdonald

Mitsubishi Chemical Holdings (MCHC) has announced plans to buy the ‘dominant’ pharma-grade HPMC capsule maker Qualicaps as the global gelatin shortage continues.

ICIG buys Tessenderlo's struggling pharma business

13-Dec-2012 By Gareth Macdonald

International Chemical Investors Group (ICIG) has bought Tessenderlo's underperforming European pharmaceutical intermediates and API business.

IPEC Americas announces results of exec board elections

13-Dec-2012

Representatives from Pfizer, J&J, Dow Corning and EMD Millipore will join IPEC Americas’ executive board and lead the excipient industry organisation as it moves to a new HQ.

CDER wants pill makers to find alternatives to DBP and DEHP plasticisers

06-Dec-2012 By Gareth Macdonald

The US CDER wants drugmakers to find alternatives to two common plasticisers used in tablet coating after studies link them to developmental and reproductive defects in animals.

SGS and blue inspection body to be excipact trained

29-Nov-2012 By Gareth Macdonald

The group behind the excipient certification scheme Excipact will train SGS and blue inspection body GmbH auditors under agreements signed this week.

Industry coalition questions USP comments on elemental impurities harmonisation

29-Nov-2012 By Gareth Macdonald

The industry group that prompted the USP to delay new elemental impurities standards says even when completed, ICH Q3D will take time to implement.

Euticals suspends production after high levels of explosive chemical found at UK site

26-Nov-2012 By Natalie Morrison

Euticals Limited has halted API production at its Welsh site after local authorities found it was housing “substantial” quantities of a potentially explosive chemical.

News from CPhI

India will back pharma SMEs in $500m finance scheme

20-Nov-2012 By Natalie Morrison

The Indian Government plans to offer financial assistance to small and medium pharma enterprises (SMEs) in a bid to drive the industry.

Indian regulations will hike costs but market will remain competitive, Government tells IPT

15-Nov-2012 By Natalie Morrison

Domestic regulatory efforts to improve ingredient quality will increase costs but Indian industry will remain competitive, according to the Secretary of Commerce.

Xi Jinping wants to improve medical care in China

15-Nov-2012 By Gareth Macdonald

New Communist Party General Secretary Xi Jinping wants to improve medical care and says China needs to “learn more about the world.”

Lack of harmonization on impurities a concern, says industry group

14-Nov-2012 By Gareth Macdonald

An industry consortium has asked the USP to delay new elemental impurities chapters on concerns that lack of harmonization with ICH Q3D will create compliance difficulties, shortages and additional costs.

EXCLUSIVE - update

Source bovine materials from BSE-free Australia or NZ: CEO's plea to regulators

14-Nov-2012 By Natalie Morrison

Regulators should force pharmaceutical firms to source from BSE-safe countries according to Rocky Mountain Biologicals' CEO.

SAFC expands PharmaGrade raw material portfolio to meet demands

14-Nov-2012

SAFC has added 25 new raw materials to its portfolio of PharmaGrade products, expanding its early phase material offering.

BASF shake-up wont impact pharma business; China expansion

06-Nov-2012 By Gareth Macdonald

The organisational changes BASF announced yesterday will not impact drug ingredients or excipients but intermediates will be rejigged.

Evonik hikes amino acid prices in face of rising maize and sugar costs

24-Oct-2012 By Natalie Morrison

Evonik has raised the price of its pharmaceutical amino acids as a result of rising maize and sugar costs.

News from AAPS

Low API and excipient volumes vital to win authorisation under EU PIP says EMA

23-Oct-2012 By Natalie Morrison

Pharmas should use lower API and excipient volumes if seeking authorisation under the EU Paediatric Investigation Plan (PIP) says the EMA.

Dispatches from AAPS

Capsugel expands liquid fill capsule capabilities

17-Oct-2012 By Natalie Morrison

Capsugel has expanded its Licaps liquid fill capsule line with a new facility in the US.

Indian pharma regulations should not change to suit others, says the Government

15-Oct-2012 By Natalie Morrison

Indian regulations should not change to suit Western GMP standards, according to the country’s Deputy Drug Controller.

Mutual recognition agreements will solve global GMP woes, says EFCG

10-Oct-2012 By Natalie Morrison

Mutual recognition agreements between Western regulators would help ensure a safe API supply chain, according to the EFCG.

Quadro Engineering believes it has solved the "wet milling problem"

02-Oct-2012 By Natalie Morrison

Quadro Engineering says its new wet milling tech will improve API production by operating at speeds previously thought impossible.

Could oral testosterone replacement therapy come in a capsule?

26-Sep-2012 By Natalie Morrison

Clarus Therapeutics believes it has solved the oral availability problem for testosterone replacement therapy.

Alchem ups sennoside production in face of pharma demand

25-Sep-2012 By Natalie Morrison & Gareth Macdonald

Alchem International has expanded its sennosides production facility in India in a bid to meet pharma demand.

GM corn could soon be used to make drugs

20-Sep-2012 By Natalie Morrison

Genetically modified corn could soon be used to mass-produce the enzymes used in rare-disease therapies, according to new research.

Arkema rejigs to grow specialty chem business

20-Sep-2012

Arkema has restructured its business as part of its bid to generate €8bn ($10.3bn) in 2015 and become a world leader in the specialty chemicals sector.