Excipients, raw materials & intermediates

Acura pays Pfizer $2m to buy back anti-abuse tech and relaunch Oxecta drug

15-Apr-2014 By Dan Stanton

Acura has reacquired the rights to its opioid abuse-deterrent technology from Pfizer and is looking for pharma partners to relaunch its oxycodone HCL drug Oxecta.

UPDATE

Sugar in place of APIs discovered in EU's largest fake drug seizure

14-Apr-2014 By Dan Stanton

Fake aspirin and anti-diarrhoeal medicines were amongst the largest counterfeit drugs haul discovered to be destined for the European Union, a French customs official says.

IPEC asks excipient industry to provide insight on elemental impurities

10-Apr-2014 By Zachary Brennan

IPEC Americas has released a standardized letter and template that pharmaceutical companies can use to collect available information from their suppliers regarding elemental impurities in excipients.  

Mushroom enzymes could work cost saving magic for API makers say researchers

09-Apr-2014 By Gareth Macdonald

Fungi have no place in an API facility, but soon enzymes derived from them may be commonplace say scientists developing oxidoreductases for cost and time saving industrial applications.

Two giant leaps for MannKind? US approval nod good for delivery tech too

02-Apr-2014 By Gareth Macdonald

A US FDA review panel has recommended that Afrezza be approved and concluded that the technology used to deliver MannKind's inhalable insulin does not damage airways or lung cells.

US excipients market to rise to $2B by 2018, study finds

31-Mar-2014 By Zachary Brennan

The rapid growth of the US excipients market is going to be driven mostly by rises in polymers, gelatins and sugar alcohols, according to a new study.

US FDA issues new bioavailability guidelines

25-Mar-2014 By Dan Stanton

The US FDA has published guidance of how sponsors should best document the bioavailability of products for investigational new drug applications (INDs) and new drug applications (NDAs).

news from Interphex

Lack of investment in production of low margin drugs behind shortages says expert

24-Mar-2014 By Dan Stanton

The thin profit margins associated with relatively simple sterile products has led to a reluctance to invest in operations and shortages, according to an industry expert.

Drug industry job changes: People on the move

24-Mar-2014

New hires at Merck Serono, Amgen, Takeda and Fate Therapeutics this week. It's in-Pharmatechnologist.com's people column.

Drug firms replaced as Lonza's biggest buyers in 2013

20-Mar-2014 By Gareth Macdonald

Drugmakers were replaced by buyers of cosmetics, hygiene and material protection ingredients as Lonza’s biggest customers in 2013 according to a report released by the Swiss CMO today.

Managing excipient supply needs risk guidance, not ‘fear’ says expert

19-Mar-2014 By Fiona BARRY

US pharmaceutical firms ‘fear change’ and need guidance on assessing safe excipient supply to become more like their European counterparts, says a senior IPEC expert.

Gov set on enhancing UK supply chain competitiveness

12-Mar-2014 By Gareth Macdonald

The UK Government has set out to make Britain a more attractive place from which to source drugs and ingredients by awarding a series of taxpayer funded grants to supply chain focused innovation projects.

Excipient industry group IPEC India launches after delays

10-Mar-2014

Drug excipient makers in India and those serving the market have a dedicated IPEC chapter after the delayed fifth branch of the industry group was finally formally incorporated at the end of January.

Anti-addiction formulation of super-strong opioid unclear

05-Mar-2014 By Fiona Barry

Addiction doctors have petitioned the US FDA to prevent Zohydro ER, the first single-entity hydrocodone painkiller, hitting the market this month citing its potential for abuse. Its maker, Zogenix, has been tight-lipped on whether the drug’s formulation...

Europe slow to adopt anti-abuse formulations and tech, says expert

27-Feb-2014 By Fiona Barry

European regulators have been accused of making “no attempt” to counter misuse of prescription drugs in comparison with North American efforts to reformulate and restrict addictive drugs, according to a Canadian firm testing the abuse potential of medicines.

BASF hikes ethanolamine price due to continuous demand

27-Feb-2014 By Dan Stanton

BASF has hiked its prices for ethanolamines in Europe citing continuous demand increase.

FMC asks CBC to help it become bigger in Japan

25-Feb-2014 By Gareth MACDONALD

FMC has hired Connell Brothers (CBC) to distribute its drug excipients in Japan, citing the move as a key step to building its business in the country.

Great Excipact-ations: more excipient firms certified as predicted

20-Feb-2014 By Gareth MACDONALD

Four more drug excipient suppliers have been certified under the newly independent Excipact quality scheme.

Changes proposed to US CFATS facility security rules

12-Feb-2014

It is too early to predict what impact proposed changes to US rules on chemical plant security and anti-terrorism measures would have on the drug industry according to PhRMA.

NSF acquires IPEC auditing arm

11-Feb-2014 By Zachary Brennan

NSF International has acquired the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC) as part of a way to ensure a more streamlined supplier qualification process.

Excipact scheme launched as independent not-for-profit alliance

11-Feb-2014 By Gareth Macdonald

The team behind the scheme that helped BASF, Seppic and Merck KGaA reduce their audit burdens expect more excipient suppliers to seek certification as an independent association.

Jubilant denies speculation it will sell its fine chemical business

06-Feb-2014

Jubilant Life Sciences has dismissed claims it is looking to sell off its fine chemicals business.

UK’s MHRA updates risk-based site inspection strategies

04-Feb-2014 By Zachary Brennan

The UK’s drug regulator is overhauling the way it manages its pharmaceutical manufacturer inspections to deal with its growing burden of site visits.

Pfizer, Lilly and other giants team up to fight counterfeits

30-Jan-2014 By Fiona Barry

Big pharma rivals are joining forces to pursue a new generation of sophisticated counterfeiters, according to Pfizer and Eli Lilly.

Vive l’excipact: French Seppic excipients site gets certified

27-Jan-2014

A French subsidiary of specialty ingredients firm Seppic has become the latest supplier certified under the Excipact quality scheme for drug excipients

Companies look to ramp up investments in US IV solutions as shortages persist

21-Jan-2014 By Zachary Brennan

Efforts to address the current shortage of IV fluids in the US are a placing a strain on manufacturing capabilities according to Baxter, which is investing to try and increase production capacity.

BASF becomes an excipact certified excipient maker

08-Jan-2014

Excipient production at a BASF plant in Lugwigshafen, Germany has been deemed to meet standards set out under the excipact certification scheme.

Ideal Cures launches Instacoat Lab app at CPhI India

04-Dec-2013

Ideal Cures has launched a new mobile phone ‘app’ designed to help customers make better use of its range of coating products.

BASF increases cost of intermediate solvent due to material and utility costs

02-Dec-2013 By Dan Stanton

BASF has raised the price of 1,4 Butanediol (BDO) and its derivatives, citing energy costs as a key factor.

Dispatches from AAPS

Non-oral FDCs are beneficial for patients and industry, say experts

13-Nov-2013 By Dan Stanton

Drug delivery experts say fixed dose combination (FDC) products for non-oral forms can benefit both the manufacturer and the patient.

SAFC to offer integrated catalysis services in deal with CatSci

07-Nov-2013 By Dan Stanton

CatScI says pharma demand for catalysis services is increasing due to a greater focus on economic sustainability as it inks a deal with SAFC for its chemical processes.

update

Evonik to raise excipient prices 10% in 2014 citing 'costs'

07-Nov-2013 By Gareth Macdonald

Evonik Industries has announced plans to increase what it charges for excipients used in modified release formulations next year, citing rising costs.

US FDA looks to speed placement of more inspectors in China

06-Nov-2013 By Zachary Brennan

The US FDA told us that China has “taken longer than FDA had hoped” in approving the visas of new FDA inspectors that would more than double the agency's presence in China. 

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.

News from CPhI

Second generation HPMC excipient can cut costs by 60%, says Dow

05-Nov-2013 By Dan Stanton

A new tableting excipient eliminates the need for wet granulation and saves up to 60% on overall manufacturing costs according to developer Dow.

Coalition calls on USP to use risk-based biorelevant analyses in new general chapter

05-Nov-2013 By Zachary Brennan

An IPEC-affiliated coalition is calling on USP (US Pharmacopoeia) to allow for the determination of physiologically relevant bioaccessible elemental impurity content for pharmaceutical products and components.

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.

Capsugel and Bend: 'Marriage made in heaven' as first tech transferred

31-Oct-2013 By Dan Stanton

The acquisition of Bend Research by Capsugel may be “a marriage made in heaven” for customers, the firms say, as the first drug delivery tech is transferred.

GSK partners with Brazilian chem experts to make drugmaking greener

29-Oct-2013 By Gareth Macdonald

GSK has teamed up with Brazilian researchers to develop ‘sustainable chemistry’ processes it will use to make drug manufacturing greener.

dispatches from CPhI

Risk-based supply chain management means more audits for excipient firms

28-Oct-2013 By Gareth Macdonald

Regulatory pressure for risk-based supply chain management is increasing excipient suppliers’ audit burden according to the team preparing to launch the 'excipact' certification scheme as an independent association.

UPDATE - Dispatches from CPhI

Capsugel's purchase of Bend will strengthen partnership, says Dow

28-Oct-2013 By Dan Stanton

Dow says the acquisition of partner Bend Research is “good news” and will strengthen its developments in solving solubility and bioavailability issues in drug formulation.

DISPATCHES FROM CPhI

Catalent launches softgel products at CPhI: one vegetarian, one anti-abuse

23-Oct-2013 By Dan Stanton

Catalent has announced two new softgel solutions as it adds greater versatility to its Advanced Technologies Business Unit.

Amarin supplier continues production of Omega-3s following US FDA panel decision

23-Oct-2013 By Zachary Brennan

Omega-3 supplier BASF will continue to produce the API for Amarin, as well as its competitor GlaxoSmithKline, despite an FDA panel saying that Amarin’s drug should not be approved for a broader population.

Azelis to bring PVP excipients from China to the West

22-Oct-2013 By Dan Stanton

Azelis says its partnership with JH Nanhang (JHNH) will feed a large demand for polyvinylpyrolidones (PVP) excipients and bring the China-made ingredients to new markets.

Cirrus studies formulation effects on MDI performance for US FDA

17-Oct-2013 By Dan Stanton

Cirrus Pharmaceuticals has received a grant to investigate the effect of excipient concentration and API molecule size on metered dose inhaler (MDI) formulations.

US FDA Releases ICH Draft Guideline on Elemental Impurities

16-Oct-2013 By Zachary Brennan

The US FDA has released the ICH’s guideline on elemental impurities for public comment a little more than two months after the ICH did the same.

Colorcon calls on Evonik to help sell delayed-release tech

15-Oct-2013 By Gareth Macdonald

Colorcon has called on Evonik Industries to help it sell a co-developed, delayed release pill coating technology.

Pharma Action teams with Tönnies to supply 100% German heparin

15-Oct-2013 By Dan Stanton

Pharma Action says safety of supply will counter the low costs of Chinese made heparin as it inks a joint venture with the Tönnies Group.

Nordic partners Enteris; Licenses bioavailability boosting platform

08-Oct-2013 By Dan Stanton

Enteris has secured its first partnership to develop metabolic peptides for Nordic Bioscience using an oral delivery platform it says offers unparalleled bioavailability.

Top manufacturers seek clarity on delaying, denying FDA inspections

07-Oct-2013 By Zachary Brennan

Merck, Novartis, GlaxoSmithKline, Celgene and industry groups are taking issue with recent FDA draft guidance on how manufacturers can reject or limit agency inspectors.