Excipients, raw materials and intermediates

Ingredient importers: Get ACE in place by February, says US FDA

10-Dec-2015 By Dan Stanton

A new system will simplify and speed-up US imports of pharma ingredients the FDA says, but industry needs to be on board by the end of February.

Acquired Sigma-Aldrich businesses part of Merck's Africa growth plan

26-Nov-2015 By Gareth Macdonald

New acquisition Sigma Aldrich will play a part in African growth plans in addition to giving it a presence in the preclinical services sector says Merck*.

Pharma unhappy with French 'made in EU' proposal

19-Nov-2015 By Phil Taylor

France's government has proposed new labelling for medicines that would indicate whether the contents were manufactured in or outside Europe.

Laser delivery will allow painless, needle-less vaccines

19-Nov-2015 By Fiona BARRY

A laser-based treatment will allow powdered vaccines to be delivered through the skin, scientists say.

BASF begins production at German intermediate plant

05-Nov-2015 By Dan Stanton

Production has begun at a BASF facility in Germany to help feed the growth in pharma demand for specialty amines.

Manganese-based catalyst to offer cost-effective drug properties enhancement

04-Nov-2015 By Anthony King

A manganese-based catalyst invented by chemists in Illinois could transform the solubility of drug candidates and improve their therapeutic properties.

Graphene could strip polluting medicines from wastewater

29-Oct-2015 By Phil Taylor

Pollution caused by pharmaceuticals in wastewater is a major challenge facing the industry, but researchers in Greece may have come up with a solution.

Engineered banana protein shows potential as potent antiviral

28-Oct-2015 By Staff reporter

A team of researchers has modified a lectin protein found in bananas to diminish its inflammatory properties, potentially setting it on the path to use as an antiviral.

Pay-as-you-go or unlimited access? EMD ups its risk assessment service

20-Oct-2015 By Dan Stanton

EMD Millipore will offer drugmakers two-years of unlimited access to its suite of raw materials dossiers for 20,000€ as part of its enhanced portfolio offering.

Dispatches from CPhI

EFCG: ‘API’ days for Europe as Big Pharma returns in search of quality

15-Oct-2015 By Dan Stanton

Big Pharma has returned to Europe for its API sourcing due to reasons of quality and reliability, according to the European Fine Chemicals Group (EFCG).

CPhI Worldwide 2015

Dow launches green MUPS-coating tech at CPhI

15-Oct-2015 By Fiona BARRY

Dow has revealed a polymer for multi-particulate drugs that it says is solvent-free and bypasses slow-drying water-based methods.

CPhI Worldwide 2015

If you want new excipients, regulate them, says BASF

13-Oct-2015 By Fiona BARRY

A BASF expert is calling for an independent review body for new excipients to reassure wary drugmakers of their quality.

Nisso asks Mutchler to help it communicate better with US pharma

12-Oct-2015 By Gareth Macdonald

Nisso Soda Co. has partnered with Mutchler Pharmaceutical Ingredients to try and win a greater share of the US hydroxypropyl cellulose market months after expanding production capacity.

BASF new efficiency drive may involve job cuts

05-Oct-2015 By Gareth Macdonald

BASF expects to reduce its workforce though natural employee turnover rather than redundancies as part of a new €1bn cost cutting plan.

‘First liquid aspirin’ maker seeks licensing deal

01-Oct-2015 By Fiona BARRY

Innovate Pharmaceuticals has launched what it claims is the world’s first shelf-stable liquid aspirin, and says it is on the look-out for a licensing partner for the “$500m” market.

Catalloy fined after explosion at metal catalysts plant

29-Sep-2015 By Gareth Macdonald

A UK supplier of metal catalysts to the drug industry has been fined after an explosion at its site in Widnes left an employee with minor injuries.

Evonik hikes up pharma excipient prices

28-Sep-2015 By Dan Stanton

Increasing QbD needs and a range of technical service centres have driven up the prices of Evonik’s drug delivery excipient portfolio, the company says.

Ashland to spin specialty chemicals business into standalone company

24-Sep-2015 By Dan Stanton

It will be business as usual for pharma customers as Ashland approves a plan to separate into two independent companies, the ingredients firm says.

Supersonic spray will transform bioavailability, says BASF

15-Sep-2015 By Fiona BARRY

BASF is developing extra-soluble nanoparticles for better drug delivery using faster-than-sound technology.

Low level mercury in drugs safe but EU needs to set limits say Polish researchers

07-Sep-2015 By Anthony King

The EU needs to better define mercury limits for drugs and dietary supplements say Polish researchers who want pharmaceuticals in Europe to be tested more regularly.

NIPER says API nano crystal formulation tech will cut drug costs

02-Sep-2015 By Anthony King

The National Institute of Pharmaceutical Education and Research (NIPER) in India has created and licensed technology for producing nano-crystal based medicines that it says will cut drug costs.  

To supply the Dane: Novo expects First API batch in 2020

27-Aug-2015 By Gareth Macdonald

Novo Nordisk has confirmed it will build an API plant in the US, telling this publication a desire to have manufacturing capacity in the key market for its oral diabetes candidate, semaglutide, drove the decision.

DSM says plans to cut 1,100 jobs prompted by recent pharma moves not shareholder pressure

25-Aug-2015 By Gareth Macdonald

Royal DSM will make up to 1100 staff redundant by the end of 2017 to cut costs following the formation of its Sinochem JV and pharma products deal with Patheon.

Pharma plants strike in Pakistan to protest QC rule changes

19-Aug-2015 By Fiona BARRY

Pakistani pharmaceutical manufacturers are today halting production in protest at changes to manufacturing regulations.

Excipient manufacturers raise concerns over stability testing

13-Aug-2015 By Phil Taylor

Manufacturers of excipients are being sent inappropriate requests for stability data by some regulators and pharma companies, threatening to disrupt the supply chain, IPEC claims.

Legionella bacteria force GSK to temporarily close North Carolina plant

12-Aug-2015 By Zachary Brennan

GlaxoSmithKline was forced to briefly shutter its Zebulon, NC, manufacturing facility after the company discovered legionella bacteria in one of its cooling towers.

Less than a year to risk assess excipients: IPEC Europe develops 'how to' guide

27-Jul-2015 By Gareth Macdonald

IPEC Europe has reminded drugmakers they have less than a year to risk assess all excipients used in their products under recently introduced EU rules.

IPEC calls on FDA to establish new review process for novel excipients

22-Jul-2015 By Zachary Brennan

As part of a push to bring more novel excipients to market, IPEC-Americas is calling on the FDA to create a new regulatory review process that could relieve some of the uncertainty around the use of new excipients.

Gadea's steroid intermediates biz means AMRI not reliant on Asian suppliers say execs

20-Jul-2015 By Gareth Macdonald

AMRI has bought Spanish contractor Gadea Pharmaceutical Group for $174m (€160m) to add muscle to its steroid API business and sign up more customers outside the US.

Miracle cures and ‘hot motorbikes’ or black market meds and empty shelves: Pharma in North Korea

07-Jul-2015 By Gareth Macdonald

Even if claims about Kumdang-2 are real, access to the drug and other pharmaceuticals in North Korea is limited to those who can pay black market prices according to a UK-based defector.

Canadian manufacturer hit with warning letter over cross-contamination issues

06-Jul-2015 By Zachary Brennan

Toronto-based Attix Pharmaceuticals has received a US FDA warning letter after an inspection from November and a lack of corrective actions in the company’s response to the FDA.

US FDA: Generic pills must look similar to reference drugs to minimize patient safety risk

23-Jun-2015 By Gareth Macdonald

Generic pills are a safety risk if they are too different from their reference drug according to the US FDA, which wants developers to consider physical characteristics when making copycat meds.

New nanotech excipient makes for better delayed-release drugs say researchers

22-Jun-2015 By Gareth Macdonald

Swedish scientists who developed the solubility enhancing nanotech excipient Upsalite say it can also be used to improve delayed release formulations.

CSIRO tells of sea shells that protect sensitive cures

09-Jun-2015 By Dan Stanton

A capsule inspired by the porous structure of seashells has been developed to protect drugs from extreme temperatures and could be used in controlled delivery.

update

Sobi terminates talks with unnamed suitor

08-Jun-2015 By Gareth Macdonald

Swedish Orphan Biovitrum AB (Sobi) has pulled out of talks with a suitor that was rumoured to be US drug giant Pfizer.

Pharma R&D exodus on the Horizon? EU industry bemoans funding cuts

04-Jun-2015 By Gareth Macdonald

European drug industry groups have contrasted 'misguided' cuts to the Horizon 2020 budget with US plans to increase NIH funding for science R&D under the 21st Century Cures Bill.

US FDA issues guidance on DNA-mutating pharma impurities

03-Jun-2015 By Fiona BARRY

The US FDA has issued guidance to manufacturers on impurities in finished drugs which can change human DNA and cause cancer.

US preference for ANSI 363 excipient standards will change, says EXCiPACT

03-Jun-2015 By Dan Stanton

Multinational excipient-makers will drive US interest in EXCiPACT, the industry-led certification scheme says as a UK Colorcon plant becomes the eighteenth site to receive accreditation.

Bubble delivery can rescue failing drug candidates, says Oxford team

02-Jun-2015 By Fiona BARRY

University of Oxford scientists are saving undeliverable drugs by placing them in gas bubbles for better bioavailability and fewer side effects.

April US chemical output for pharma down says ACC; SOCMA welcomes R&D tax credit move

27-May-2015 By Gareth Macdonald

US production of chemicals for the drug industry fell in April according to data released days after renewed calls for permanent tax breaks to help American manufacturers compete globally.

Grace: silica gel plant certification will cut customer audit burden

26-May-2015 By Gareth Macdonald

WR Grace says certification for its excipient plant in Germany will reduce the audit burden faced by drug industry customers.

EMA: clinical data may not be needed for topical comparisons

13-May-2015 By Fiona BARRY

The EMA (European Medicines Agency) is changing the way it assesses quality of topical drugs for marketing authorisations.

Nisso opens expanded HPC plant on back of pharma demand

11-May-2015 By Dan Stanton

Recent US FDA approval of products containing the excipient HPC has driven demand, according to Nippon Soda (Nisso) which has expanded its production facility in Japan.

Siegfried set to buy custom synthesis and API units from BASF for $300m

07-May-2015 By Dan Stanton

BASF says it remains committed to the pharma industry despite plans to divest its custom synthesis business and around 100 APIs and intermediates to Siegfried Holding.

FDA needs to conduct all generic manufacturing inspections requested by reviewers, report says

07-May-2015 By Zachary Brennan

Although the US FDA has drastically increased its preapproval inspections of generic drug makers worldwide, the agency failed to conduct all of the inspections requested by its own generic application reviewers, according to a report from the HHS Office...

BASF ups price of EOAs in Europe

05-May-2015 By Dan Stanton

BASF has hiked up the price of ethanolamines in Europe citing increased cost of raw materials and continuous demand.

IPEC says confusion around FDA review of excipients could delay ANDA review cycles

05-May-2015 By Zachary Brennan

Inaccurate and incomplete information on excipients referenced in the US FDA Inactive Ingredient Database (IID), as well as other agency policies and guidance on the review of inactive ingredients in ANDAs (Abbreviated New Drug Applications) “continue...

Indian API and generics firms want a bigger share of the Japanese market

04-May-2015 By Gareth Macdonald

Indian generics firms see opportunities in the Japanese drug market according to a trade delegation that visited Tokyo last week seeking supply contracts.

IBEF: India still attractive for Japanese pharma despite Daiichi Sankyo's Ranbaxy experience

30-Apr-2015 By Gareth Macdonald

Japanese drug firms eyeing international investments should not be put off by Daiichi Sankyo’s turbulent ownership of Ranbaxy according to an Indian delegation in Tokyo last week to seek collaborations.

Big firms dominate solubility sector but demand creating space for small players, says Kline & Co

16-Apr-2015 By Gareth Macdonald

BASF, Abitec and Gattefossé dominate the solubility excipients market but growing demand for tech to enhance API solubility is creating opportunities for smaller suppliers according to new research.