Excipients, raw materials & intermediates

BASF halts production at Ludwigshafen plant after deadly explosion

18-Oct-2016 By Gareth Macdonald

BASF is confident the shutdown of its site in Ludwigshafen, Germany will not disrupt the supply of drug excipients.

Nippon staff formed barrier to block QC lab inspection says US FDA

07-Oct-2016 By Gareth Macdonald

Nippon Fine Chemical staff formed a human barricade to prevent a US FDA team inspecting a quality control laboratory at its site in Takasago City, Japan according to a warning letter published this week.

Moody's maintains B1 rating of merger-bound Avantor

27-Sep-2016 By Gareth Macdonald

Avantor Performance Materials has had its positive rating reiterated by Moody’s just days before its merger with Nusil Technology is expected to complete.

BASF set to start making PVP in China

27-Sep-2016 By Gareth Macdonald

BASF is poised to start making polyvinylpyrrolidone (PVP) at its facility in Shanghai, China after completing work on a $70m (€62m) manufacturing expansion.

DSP: Pharmas must be open about API suppliers to fight antibiotic resistance

26-Sep-2016 By Gareth Macdonald

Drug companies need to me more open about their API suppliers to help fight the spread of antimicrobial resistance (AMR) according to DSM Sinochem Pharmaceuticals.

Cambrex bolstering API services through $25m PharmaCore acquisition

26-Sep-2016 By Dan Stanton

Cambrex will acquire clinical-scale API maker PharmaCore for $25m adding a standalone GMP facility in North Carolina approved to make Schedule II to V products.

Colorcon and Dow extend controlled release alliance

22-Sep-2016 By Staff Reporter

Colorcon and Dow have expanded a nine year controlled release alliance to include further solubility, coating and ion exchange platforms.

Saneca investing €3.5m into small-scale API capabilities

15-Sep-2016 By Staff Reporter

Saneca Pharma says the expanded capabilities will feed demand for small-scale API batches to support clients’ R&D projects.

Spain's Idifarma bolstered by investment from API maker Suanfarma

12-Sep-2016 By Dan Stanton

Spanish API maker Suanfarma has acquired a stake in contract manufacturer and spray-drying specialist Idifarma, boosting its international presence.

IPEC China joins EXCiPACT, promoting excipient safety, quality

07-Sep-2016 By Melissa Fassbender

The global excipient certification organization has announced IPEC Association (China) Limited as its fifth member, joining IPEC Europe, IPEC Americas, FECC, and PQG (UK).

Chemical fast-track could speed up nitrile drug synthesis

06-Sep-2016 By Phil Taylor

A synthetic short cut could make it easier and cheaper to produce nitrile-containing compounds, a group which includes dozens of marketed and pipeline drugs.

When it comes to vaccine adjuvants, not all alum is equal

05-Sep-2016 By Phil Taylor

Aluminium adjuvants should not be used in trial placebos according to UK scientists who say the differing physical and biological properties of alum salt forms makes some safer than others.

Grunenthal says anti-crush tech Endo uses for Opana ER helps prevent abuse

25-Aug-2016 By Gareth Macdonald

Grunenthal has reiterated the benefits of its anti-crush intac tech after licensee Endo withdrew its request to have Opana ER labelled as “abuse deterrent."

SRF board approves new chloromethane plant to meet Indian pharma demand

11-Aug-2016 By Gareth Macdonald

SRF Limited has unveiled plans for a second chloromethane plant just two months after India imposed anti-dumping tariffs on Chinese and Russian imports. 

IMCD completes Mutchler takeover to access the US pharma excipients market

09-Aug-2016 By Gareth Macdonald

IMCD has entered the US pharmaceutical market with the acquisition of specialty API and excipient distributor Mutchler.

Third strike for Wockhardt as API facility hit with US import alert

08-Aug-2016 By Dan Stanton

The US FDA has banned products from a third Indian manufacturing plant operated by Wockhardt.

WR Grace opens pharma-focused QC lab and predicts second half intemediates growth

08-Aug-2016 By Gareth Macdonald

W.R. Grace has opened a pharma quality control laboratory at its manufacturing facility in Albany, Oregon and predicted higher drug intermediates sales in the second half of the year.

update

MilliporeSigma has signed an excipient distribution deal with PCAS

18-Jul-2016 By Gareth Macdonald

MilliporeSigma will distribute range of lactic acid sustained release excipients under a deal with French developer PCAS.

AMRI completes €315m Euticals takeover to add capacity to API business

12-Jul-2016 By Gareth Macdonald

AMRI has completed the acquisition of Italian API firm Euticals for €315m ($350m).

Phalanx Labs banned from shipping APIs to US after refusing inspection

17-Jun-2016 By Gareth Macdonald

The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.

Oasmia reviewing proposals from firms interested in API solubility enchancement tech

31-May-2016 By Gareth Macdonald

Oasmia Pharmaceutical AB has started reviewing ‘term sheets’ from firms interested in its vitamin A-derived drug delivery tech.

Colorcon to buy BASF's Kollicoat coating system product

25-May-2016 By Gareth Macdonald

Colorcon will buy BASF’s Kollicoat excipient coating system product line in a deal announced today.

Italian regulator slams simvastatin-maker Krebs for GMP deviations

23-May-2016 By Gareth Macdonald

APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.

Olon SpA to buy Infa Group

23-May-2016 By Gareth Macdonald

Italian API firm Olon SpA has signed a definitive agreement to buy Infa Group in a deal designed to strengthen its portfolio.

Wuxi sets up drug supplier network to ease pharma sourcing

27-Apr-2016 By Staff Reporter

WuxI AppTec has a chemical trading network designed to help drug manufacturers source more efficiently.

BioCellChallenge granted US patent for antibody delivery tech

20-Apr-2016 By Dan Stanton

Triazamacrocyclic lipid complexes increase the efficiency of antibody-drug conjugates (ADCs) by delivering the payload right into the heart of a cancer cell, says BioCellChallenge.

PCI Synthesis sets up polymers development lab

20-Apr-2016 By Gareth Macdonald

API manufacturer PCI Synthesis has set up a polymer development group citing growing drug industry demand for advanced coating technologies and excipient technologies.

European group responds to Indian proposal to replace gelatin in capsules

12-Apr-2016 By Gareth Macdonald

A European chemical industry group has reiterated that gelatin is safe after Indian regulators called for feedback on a plan to replace the excipient with cellulose in pharmaceutical capsules.

India seeks input on proposal to replace gelatin with cellulose in capsules

11-Apr-2016 By Gareth Macdonald

Indian regulators have called for industry feedback on a proposal to replace gelatin in capsules with cellulose.

MannKind waves 'au revoir' to Sanofi as it regains Afrezza rights

06-Apr-2016 By Dan Stanton

The rights to inhaled insulin drug Afrezza have returned to Mannkind Corporation, three months after Sanofi terminated its commercialisation deal.

BASF extends excipient range with 'dust-free' coating alternative

04-Apr-2016 By Gareth Macdonald

BASF has expanded its Kollicoat range of polymer excipients with a product dust-free alternative to enteric coatings.

Revised water for injection monograph allows use of cheaper and greener alternatives to distillation

31-Mar-2016 By Gareth Macdonald

The European Pharmacopeia Commission has adopted a revised monograph that allows a broader range of purification methods to be used for the production of water for injectable pharmaceuticals.

French regulators report GMP failings at Anuh Pharma API processing plant

30-Mar-2016 By Gareth Macdonald

Anuh Pharma has breached GMP rules at its API processing facility in Boisar, India say French regulators who visited the site last month.

Dipexium reports milestones in manufacturing of its antimicrobial peptide

24-Mar-2016 By Dan Stanton

Dipexium Pharmaceuticals has successfully scaled-up API for its antimicrobial peptide phase III candidate Locilex, made from the skin of the African Clawed Frog.

Martindale removes povidone in oral methadone reformulation

21-Mar-2016 By Dan Stanton

Martindale Pharma will relaunch its opioid substitution therapy in Scandinavia after reformulating the oral solution to remove the excipient povidone.

Plant-based vaccines poised to challenge $4bn seasonal flu shot market

14-Mar-2016 By Phil Taylor

An influenza vaccine produced in tobacco plants could make a big impact in the market if it reaches the market in the US in time for the 2018-19 flu season, says a market analyst.

Pollution from antibiotic plants a hot topic at DCAT week

Society paying for ‘cheap’ antibiotics from suppliers that pollute says DSM-Sinochem

14-Mar-2016 By Gareth Macdonald

API makers that don’t treat wastewater to cut costs and keep prices low are spreading antibiotic resistance says DSM-Sinochem, which wants drug companies to stop buying from firms that “distort” the market.

Life science becoming ‘growth engine’ following Sigma-Aldrich buy, Merck

10-Mar-2016 By Dan Stanton

Germany’s Merck expects to achieve cost synergies of €90m ($98m) in 2016 from the integration of Sigma-Aldrich which the firm acquired in November.

Crossject still on course for launch of first 'supergeneric' next year

10-Mar-2016 By Phil Taylor

With a new manufacturing deal in place, Crossject is on course to launch the first product based on its needle-free injector system next year.

US FDA backlog holding up revamp of inactive ingredients database

07-Mar-2016 By Phil Taylor

The process of sorting out problems with the US FDA's controversial Inactive Ingredients Database (IID) is shaping up to be a huge task, particularly as the agency is working through a backlog of missing updates extending back several years.

EXCiPACT's excipient certification ambitions extend well beyond Europe

01-Mar-2016 By Phil Taylor

Three years since it was set up, excipient certification organisation EXCiPACT is expanding beyond its European heartland to other areas of the world.

'Sponsor an excipient' campaign launched by child formulation group

24-Feb-2016 By Phil Taylor

A European project aimed at improving formulations for children is seeking industry help to develop a database on excipient safety.

Grünenthal formulates deal with Patheon for anti-abuse technology

23-Feb-2016 By Dan Stanton

Grünenthal has selected Patheon as its preferred development partner for its anti-abuse formulation platform INTAC, based on Hot Melt Extrusion (HME) technology.

MHRA concerned about pharma's preparedness for excipient risk assessments

22-Feb-2016 By Phil Taylor

There are concerns that pharma companies are not fully prepared to meet the new requirements on risk-assessment for excipients, even though the deadline is just a few weeks away.

Capsugel: Pulmatrix deal brings us to ‘the forefront of inhalation delivery’

18-Feb-2016 By Dan Stanton

Capsugel has come on leaps-and-bounds since it was spun-out from Pfizer, the firm says as it inks a deal with Pulmatrix to develop inhaled therapeutics.

European Pharmacopoeia looks to international experts to help harmonization

16-Feb-2016 By Phil Taylor

The European Pharmacopoeia Commission (Ph. Eur.) has decided to recruit international experts to ensure the compendium evolves with the globalisation of the pharma industry.

As Excipacted? Ashland plant certified GMP compliant under European industry-led scheme

15-Feb-2016 By Gareth Macdonald

An Ashland excipient facility in Kentucky has become the first US plant certified under Excipact, the European industry-led GMP quality scheme.

Evonik expands silanes distribution deal with Safic-Alcan

10-Feb-2016 By Gareth Macdonald

Safic-Alcan will sell chemicals used in the synthesis of antibiotics and APIs to drug ingredient firms in Italy under a new deal with Evonik.

AstraZeneca: China formulated anaemia drug on fast-track, but timeframes vague

09-Feb-2016 By Dan Stanton

AstraZeneca has reformulated roxadustat using materials sourced in China to make it eligible for fast track review through the country's new "green pass" process.

Albumedix buys Eleven's half-life boosting albumin assets

29-Jan-2016 By Gareth Macdonald

Novozymes’ albumin technologies division Albumedix has bought Eleven Biotherapeutics’ half-life extension assets.