APIs (active pharmaceutical ingredients)

Novasep latest firm to invest in ADC capacity

24-Jul-2012

Novasep has joined the growing number of manufacturers betting on the antibody drug conjugate (ADC) market with a €3m investment at its plant in Le Mans, France.

EXCLUSIVE

Invest in African R&D to boost manufacturing: WAPMA and PMGMAN's plea

23-Jul-2012 By Natalie Morrison

WAPMA and PMGMAN are calling on African Governments to pump more money into R&D in order to boost the continent’s pharmaceutical manufacturing sector.

Indian API production takes hit as APPCB shuts 12 plants

18-Jul-2012 By Natalie Morrison

API production in India will take a hit this week with plant closures for Aurobindo, Hetero Drugs, Divis Pharmaceuticals, and Sri Krishna Pharmaceuticals following allegations of environmental wrongdoing.

Nanoshells could solve oncology dual delivery riddle

18-Jul-2012 By Natalie Morrison

Hollow nano shells capable of holding both cancer fighting drugs and immune-system boosters could be the solution to oncology’s greatest delivery riddle, according to Yale University researchers.

Fine chemical earnings grow at Albemarle in Q2

18-Jul-2012 By Gareth Macdonald

Fine chemicals were one of few positives for Albemarle in the second quarter according to the US chemicals firm’s latest results.

Prosonix teams with ICL to assess MCPs for COPD and asthma

11-Jul-2012 By Gareth Macdonald

Prosonix aims to develop new treatments for respiratory diseases though an R&D accord formed with Imperial College London (ICL).

Albemarle expands API capacity

10-Jul-2012

Albemarle has increased production capacity at its plant in Michigan, citing demand for custom and generic APIs as the driver.

Lipotec pharma units not included in Lubrizol takeover

09-Jul-2012

The takeover of peptide-based actives developer Lipotec by industrial chemicals firm Lubrizol will not include the Spanish firm’s pharma business.

UPDATE

‘Just add water’ for ease of cleaning HP production tech, says Bosch

05-Jul-2012 By Natalie Morrison

‘Just add water’ as a preparation for cleaning the stand-in-place tech used to produce HP compounds, says Bosh’s Johannes Rauschnabel.

The quest for more understanding is behind the single use boom: Pall and Thermo Fisher

03-Jul-2012 By Natalie Morrison

The implementation of single use technology in the biopharmaceutical fill and finish process has seen a massive uptick recently because of better industry understanding, according to Pall’s Bruce Rawlings.

ScinoPharm to invest in cancer drug capacity

02-Jul-2012 By Gareth Macdonald

API maker ScinoPharm is to invest in cancer drug and injectables capacity, citing current global shortages as a driver for its decision.

A new easy way to "clean" pharma ingredients; study

28-Jun-2012 By Natalie Morrison

Scientists have uncovered a new simple way to “clean” genotoxic impurities (GTIs) in drug ingredients by mixing the solution with contamination-eating scavengers.

EMA adds Q&A on genotoxic impurities & residual solvents

26-Jun-2012 By Nick Taylor

The EMA has updated its quality documents with sections on genotoxic impurities, residual solvents, and heavy metal catalyst residues.

Is drug delivery by skin the solution to bioavailability woes? report from Achema

21-Jun-2012 By Natalie Morrison

Drug regulators and the biomanufacturing industry need to embrace drug delivery via the skin to solve solubility problems with peptides and proteins, according to Across Barriers’ Udo Bock.

FDA sends closeout letter to end Akzo API plant warning

18-Jun-2012 By Nick Taylor

The US FDA has posted a closeout letter to an AkzoNobel Mexican API plant seven months after it warned the facility.

New modulator to boost protein production, says ProBioGen

14-Jun-2012 By Natalie Morrison

ProBioGen has launched a new pathway modulator for mammalian cell lines that it says improves protein production efficiency.

Indian SMEs need Gov support to comply with GMPs; report

14-Jun-2012 By Nick Taylor

The Indian Government must better support modernisation efforts at small businesses to boost GMP compliance, a report found.

UPDATE

Pricing schemes stunts UK pharma manufacturing market's growth: report

07-Jun-2012 By Natalie Morrison

The UK pharma manufacturing market is predicted to see a modest 2.7 per cent growth over the next five years largely due to pricing schemes set by the Government, according to a new report.

FDA warns 8 manufacturers for failing to register plants

07-Jun-2012 By Nick Taylor

The US FDA has sent warning letters to eight biopharma companies for failing to register production facilities.

Pfizer confirms 177 job cuts at Irish API plants

06-Jun-2012

Pfizer has confirmed 177 staff working for production facilities in Ireland will be cut.

Lack of “horsepower” prompts sale of AMPAC aerospace biz

06-Jun-2012 By Nick Taylor

AMPAC is selling its aerospace business after deciding it lacked the “horsepower” to grow both it and the pharmaceutical unit.

EMA posts draft guidelines on transgenic animal production

04-Jun-2012

The EMA has published draft guidelines on ensuring drug quality when producing APIs in transgenic animals.

FDA alert drives cephalosporin sales drop at Aurobindo

31-May-2012 By Nick Taylor

A FDA import alert drove a double-digit drop in quarterly cephalosporin sales at Aurobindo and led to a one-third cut in full year earnings. 

USP replaces 'out of date' impurity testing standards

29-May-2012 By Natalie Morrison

The US Pharmacopeial Convention (USP) has introduced new elemental impurity standards to replace what it says were outdated guidelines.

EMA okays MabThera after contamination at Roche site

28-May-2012 By Nick Taylor

The EMA has cleared the Roche oncology blockbuster MabThera after concluding contamination of API bioreactors poses little threat.

UPDATE

A closer bond is key to inhaled delivery success: Prosonix

22-May-2012 By Natalie Morrison

Prosonix says its new ‘smart’ excipient-free drug particles can improve the delivery of inhaled combination therapies.

The single-use age has dawned, says ThermoFisher

21-May-2012 By Natalie Morrison

Developments in single-use technology signals the end for clean-in-place biomanufacturing methods, according to ThermoFisher’s Bill Whitford.

Round-up of new pharmaceutical manufacturing facilities

16-May-2012 By Natalie Morrison

in-PharmaTechnologist.com presents the latest new facilities to spring up all over the world, including a plasma-based therapy expansion for Baxter, a North African foray for Julphar, and a supply chain step-up for Vetter.

Flamma adds commercial scale abilities for gas

15-May-2012

Flamma now has the ability to use ammonia gas in commercial scale API production after buying a facility near Milan, Italy.

Orchid net profit tumbles as traumatic 2012 ends on a low

15-May-2012 By Nick Taylor

Fourth quarter net profit at Orchid fell by two-thirds as the Indian API manufacturer ended a difficult year on a low.

ICH sends Q11 guidelines to EU, US & Japanese regulators

14-May-2012 By Nick Taylor

The ICH has sent its Q11 guidelines on APIs to regulatory bodies in the US, European Union and Japan for adoption.

AMPAC Fine Chemicals posts loss despite anti-viral surge

10-May-2012 By Nick Taylor

The return of antiviral sales helped AMPAC Fine Chemicals grow sales in the second quarter but it still posted an operating loss.

BASF buys omega-3 maker Equateq citing pharma potential

09-May-2012 By Gareth Macdonald

BASF has bought omega-3 fatty acid maker Equateq, citing its pharmaceutical and dietary supplements businesses as key beneficiaries.

Sub-Saharan is "attractive" emerging market, says Sandoz

26-Apr-2012 By Natalie Morrison

Sub-Saharan Africa is a “very attractive market” because of local leaders’ new focus on supporting generics makers, according to Sandoz.

Granules’ profit up 43% in FY12 despite ‘dynamic’ raw materials prices

25-Apr-2012 By Gareth Macdonald

Fluctuating raw material prices mean market knowledge is a must for companies competing in the intermediates and ingredients space according to Granules India.

AstraZeneca goes Dutch on discovery with split contracts for BioFocus and Argenta

14-Mar-2012 By Gareth Macdonald

UK drug major AstraZeneca has contracted BioFocus and Argenta to provide it with discovery services just weeks cutting its internal R&D capacity. 

AMPAC sales jump 50% on return of antiviral revenues

09-Feb-2012 By Nick Taylor

AMPAC Fine Chemicals posted a 50 per cent jump in revenues after the return of sales from its antiviral business.

AMRI posts Q4 loss but expects contracting revs to grow in 2012

08-Feb-2012 By Gareth Macdonald

AMRI posted a Q4 loss on lower sales but predicts that contracting revenues and margins will increase in 2012 thanks to cost cutting measures and new contracts

Cambrex on takeover hunt amid pharma fine chem consolidation

08-Feb-2012 By Nick Taylor

Cambrex expects fine chemical consolidation to continue this year and is being “proactive” in its hunt for takeover targets.

CMO news roundup – Foster, Excella, Catalent and RohnerChem

02-Feb-2012 By Gareth Macdonald

A round-up of news in the contract manufacturing space, with developments at Foster Delivery Sciences, Excella, Catalent and RohnerChem.

DSM signs MoU with AIBN on biologics commercialisation

20-Dec-2011 By Gareth Macdonald

DSM Biologics will work with the Australian Institute for Bioengineering and Nanotechnology (AIBN) on the commercialisation of development-stage biologics projects.

AMPAC posts Q4 loss as process improvement drags on profits

15-Dec-2011 By Nick Taylor

AMPAC posted a fourth quarter loss as process improvement difficulties offset rising demand for CNS and oncology ingredients.

Solvias and RohnerChem team on API development and manufacturing

05-Oct-2011 By Gareth Macdonald

Solvias and RohnerChem have set up a research and manufacturing services partnership designed to accelerate the production, scale-up and commercialisation of APIs.

Aesica plans expansion in US & Asia after investment

03-Oct-2011 By Natalie Morrison

CDMO Aesica is to add manufacturing capacity in Asia and the US following a cash injection from private equity firm Silverfleet Capital.

Lonza inks stem cell production pact with Mesoblast

28-Sep-2011 By Nick Taylor

Lonza may build a stem cell production facility dedicated to manufacturing Mesoblast products after inking an alliance.

CMLE OKed to start commercial API production at Netherlands plant

27-Sep-2011 By Gareth Macdonald

Cambridge Major Laboratories Europe (CMLE) is set to start commercial API manufacturing at its facility in the Netherlands after approval by Dutch regulators.

Rx-360 begins audit sharing to raise ingredient quality

21-Sep-2011 By Nick Taylor

Rx-360 has begun its audit sharing programme to increase knowledge about suppliers and the quality of pharmaceutical raw materials.

Lonza MA plant sent FDA GMP warning letter about Eisai API

14-Sep-2011 By Nick Taylor

The FDA has sent a warning letter to Lonza’s Hopkinton, MA plant after inspectors found faults with how it produces an oncology API for Eisai.

Biocon building Malaysia plant to serve Pfizer insulin deal

14-Sep-2011 By Nick Taylor

Biocon has begun work on the Malaysian biopharm plant that will serve its deal with Pfizer, and is now providing Lipitor ingredients.

Ampac posts loss as volume shortfall offsets sales gains

16-Aug-2011 By Nick Taylor

Surging anti-viral sales drove fine chemical growth at Ampac in Q3, but the unit posted a loss after missing efficiency and throughput targets.