Excipients, raw materials and intermediates

Concerns climate change will see tick-borne diseases spread to the UK are legitimate, says PHE

15-Apr-2015 By Gareth Macdonald

Concerns climate change will see malaria, West Nile virus and chikungunya spread to the UK are legitimate according to Public Health England, even though no insects carrying such diseases have been detected to date.

Biocon's Syngene in silent period but lays plans for API plant in India

07-Apr-2015 By Dan Stanton

Biocon subsidiary Syngene says it intends to build a commercial manufacturing plant for APIs and intermediates in Mangalore, India.

Capsugel invests in vegetarian capsules citing demand for lower moisture content and API cross-linking risk

26-Mar-2015 By Gareth Macdonald

Capsugel will invest $25m (€22m) to expand production of vegetarian-friendly drug and food supplement capsules.

GMP for excipients: new EU rules on raw materials, packaging, tracking

25-Mar-2015 By Fiona BARRY

The European Commission has published guidelines on GMP excipients after a two-year consultation.

Register now for our free online event

The latest developments in drug excipients: Exclusive online event

25-Mar-2015 By Staff Reporter

Want the latest market information, and scientific insights in the pharmaceutical excipients market? Then join us at our free online event, Excipients Innovations 2015.

NSF publishes first US standard for pharmaceutical excipients

17-Mar-2015 By Zachary Brennan

NSF International has published a new standard and developed an auditing program that can help pharma companies verify regulatory compliance and strengthen safety and quality across their excipient supply chain.

Porton Fine Chem buys fellow China intermediates firm Dongbang

16-Mar-2015 By Gareth Macdonald

Porton Fine Chemicals will buy fellow China-based firm Jiangxi Dongbang Pharmaceutical adding intermediates for antivirals and cholesterol busters to its portfolio.

Novacyl’s acetyl salicylic acid plant in Thailand hit with FDA warning letter

11-Mar-2015 By Zachary Brennan

For the second time this year, the FDA has issued a warning letter to API (active pharmaceutical ingredient) and intermediate manufacturer Novacyl and this time it’s for the company’s manufacturing site in Thailand.

Johnson Matthey builds HPAPI site in Scotland

11-Mar-2015 By Fiona BARRY

API- and catalyst-maker Johnson Matthey has built high containment facilities for potent products at its site in Edinburgh, Scotland.

Health Canada looks to crack down further on noncompliant manufacturers

04-Mar-2015 By Zachary Brennan

Health Canada is telling drug and API manufacturers that it’s going to ramp up announced and unannounced inspections due to concerns raised around APIs and data integrity, and the findings will be published online beginning next month.

Hundreds of API suppliers with plants in new Indian state Telangana need to update EDQM

04-Mar-2015 By Gareth Macdonald

As many as 450 API and intermediate suppliers in India's newest State - Telangana – need to log their changed addresses with the EDQM before August.

Apax's proposed Azelis takeover backed by unions

25-Feb-2015 By Gareth Macdonald

Apax Partners says workers' unions have backed its plan to buy a controlling stake in chemical distributor Azelis from fellow private equity firm 3i.

Facility already supplying Granules' JV partner Ajinomoto Omnichem with validation batches

Granules predicts US and EMA approval for new API plant in two years

23-Feb-2015 By Gareth Macdonald

An API and intermediates plant set up by Granules India and Ajinomoto Omnichem is a step closer to opening after an offical inauguration ceremony last week. 

Drug delivery tech’s shares skyrocket as it helps Novo Nordisk clear Phase II hurdle

23-Feb-2015 By Zachary Brennan

A potential Type 2 diabetes drug from Novo Nordisk has met the primary endpoint of a Phase II trial and shares of Emisphere Technology, which helped to formulate the oral version of semaglutide, jumped by as much as 70% on Friday.

IPEC raises concerns over FDA guidance related to inactive ingredients

19-Feb-2015 By Zachary Brennan

The International Pharmaceutical Excipients Council of the Americas (IPEC) is raising concerns with the US FDA over ANDA (abbreviated new drug application) guidance related to excipients.

SGS rolls out latest Ph.Eur. amino acid impurities testing method at German lab

18-Feb-2015 By Gareth Macdonald

SGS will soon be able to test up to 30 batches of amino acids for impurities per month after adding new analytical methods to those offered at its laboratory in Taunusstein, Germany.

GSK to consolidate vaccines R&D ahead of Novartis unit takeover

09-Feb-2015 By Gareth Macdonald

GSK will close a vaccine R&D lab in Montana and establish a centralised development hub as it prepares to takeover Novartis jabs unit.

Cambrex: ‘Either we invest now or turn away API business”

09-Feb-2015 By Dan Stanton

Ongoing demand for large-scale APIs combined with high capacity utilization has driven Cambrex Corporation to allot up to $85m (€70m) for manufacturing expansion in 2015.

Vertellus buys antiretroviral API reagent plant from Dow

04-Feb-2015 By Dan Stanton

Specialty chemicals firm Vertellus will continue to supply antiretroviral drugmakers sodium borohydride following its takeover of a Dow plant in Washington State.

Johnson Matthey posts higher Q3 API profits; Pfizer patent spat continues

28-Jan-2015 By Gareth Macdonald

Johnson Matthey saw demand for ADHD APIs increase in the third quarter, while sales of its pain management ingredients and bulk opiates declined.

China patent gives Provectus green light to find partner for melanoma candidate, PV-10

27-Jan-2015 By Gareth Macdonald

China has told Provectus Biopharmaceuticals it will grant a patent for the method used to make the API in its skin cancer drug candidate, PV-10.

Halal and Kosher stamps of approval for pregnancy drug

26-Jan-2015 By Fiona BARRY

A morning sickness drug made by Duchesnay USA will now display Halal and Kosher symbols – a move the company said is the first case of Kosher certification for an oral prescription drug in the US.

BASF to take on Asian PVP producers and target generics firms with new capacity in China

23-Jan-2015 By Gareth Macdonald

BASF will spend €56m ($62m) to increase production capacity for the excipient PVP by expanding existing plants and introducing manufacturing capabilities at its facility in Shanghai, China.

Insulin in sea snail venom could be used by drug developers

20-Jan-2015 By Dan Stanton

Venom produced by sea snails could be used in designing human insulin analogues or as painkiller drugs, according to a University of Utah scientist.

Novozymes predicts half-life boost for pharma business, but lets long term rev forecast slide on oil prices

20-Jan-2015 By Gareth Macdonald

Novozymes finished 2014 with higher pharma revenues thanks in part to GSK's adoption of its albumin half-life extension technology, Veltis.

USP pushes back deadline for elemental impurities compliance to 2018

20-Jan-2015 By Zachary Brennan

In order to align more closely with ICH’s Q3D guideline for elemental impurities, USP has pushed back until 2018 when its chapter on elemental impurities will apply to industry.

MannKind: Small step for delivery tech R&D after Afrezza's giant leap

19-Jan-2015 By Dan Stanton

MannKind’s development of new drugs with the delivery technology used in its inhalable insulin drug Afrezza will progress without founder Alfred Mann at the helm.

Bile duct cancer breakthrough will not stretch paclitaxel supplies says analyst

14-Jan-2015 By Gareth Macdonald

Synthetic paclitaxel production methods can support expanding market and new indications according to market analysis group.

Capsugel buys ionic liquid tech IP to enhance lipid-based drug solubility

12-Jan-2015 By Dan Stanton

Capsugel has acquired a technology platform which uses ionic liquids to enhance the solubility of lipid-based drug delivery systems.

Oil's well that ends well? Low Brent crude price a boon for pharma says analyst

07-Jan-2015 By Gareth Macdonald

Falling oil prices will cut drug industry materials, manufacturing and logistics costs, and protect firms at risk of generic competition in 2015 according to one industry analyst.

Italian Medicines Agency withdraws GMP certificate from Indian manufacturer

06-Jan-2015 By Zachary Brennan

The agency issued a warning letter and withdrew the GMP (Good Manufacturing Practice) certificate from Hyderabad, India-based Sri Krishna Pharmaceuticals for 10 GMP deviations found during an inspection at its Nacharam granulation plant in December.

Rouble trouble: Big Pharma exposure to Russian currency volatility limited

17-Dec-2014 By Gareth Macdonald

Big Pharma firms’ exposure to Russia’s volatile rouble is limited and planned manufacturing investments will go ahead according to observers.

IPEC-Americas aims to make drug excipient users TUPP aware

15-Dec-2014 By Gareth Macdonald

Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.

Merck & Co set to be superbug-busting superstar despite US Cubicin ruling, analyst

10-Dec-2014 By Gareth Macdonald

Cubist will give Merck & Co leadership of the antibiotics sector according to one analyst who says renewed interest expressed by GSK, Roche and Sanofi has not produced any Ph III candidates.

Axim to build Dutch facility for cannabinoid-based chewing gum drug

04-Dec-2014 By Dan Stanton

A company developing a pharmaceutical chewing gum containing cannabinoids extracted from marijuana has announced plans to build a manufacturing facility in the Netherlands.

German regulators hit Ranbaxy with another warning letter

03-Dec-2014 By Zachary Brennan

Another warning letter has landed in the hands of Ranbaxy execs, this time from German regulators charging the company with failing to comply with GMP standards.

EMA seeking drugmaker feedback on cyclodextrin and propylene glycol labelling plan

03-Dec-2014 By Gareth Macdonald

The EMA has called for feedback on plans to require drugmakers to state whether their drugs contain solubility-enhancing cyclodextrin excipients.

Johnson Matthey acquires API capacity in Scotland

03-Dec-2014 By Zachary Brennan

Johnson Matthey has completed its acquisition of API and pharmaceutical intermediate manufacturing capacity in Scotland. 

Advanced aspirin aspirations ailing? Sanofi and Pozen terminate deal

02-Dec-2014 By Gareth Macdonald

Sanofi and Pozen have dissolved a $35m (Eur28m) ‘advanced aspirin’ partnership less than a month before the US Food and Drug Administration (FDA) decides whether to approve the new drug.

Chinese excipient market set to more than double by 2017

26-Nov-2014 By Zachary Brennan

With more than 90 excipient manufacturers in China dedicated to the pharma industry, the country expects its output of excipients to more than double to about $8.9bn (€7.1bn), according to a new report.

EMA adopts guidelines on phthalate excipients, cross-contamination in manufacturing

25-Nov-2014 By Zachary Brennan

The two guidelines offer help to manufacturers looking to use potentially hazardous phthalates as excipients in drugs, as well as those that have shared facilities where multiple drugs are produced.

$15k and API info: FDA releases guide to registering drug compounders

24-Nov-2014 By Fiona Barry

The US Food and Drug Administration (FDA) is encouraging hospitals to purchase their compounded drugs from organisations registered as outsourcing facilities, and has issued guidance on accreditation.

Big Pharma has improved access to meds since 2012 but marketing practices still a concern says AMF

17-Nov-2014 By Gareth Macdonald

Ongoing concerns about marketing practices have taken the shine of a report suggesting Big Pharma efforts have improved parients' access to drugs in developing countries over the past two years.

Dispatches from AAPS

Inhaler delivered peptide could prevent LDC deaths during childbirth, says GSK

04-Nov-2014 By Dan Stanton

Inhaled delivery of the labour inducing peptide oxytocin could help prevent millions of deaths in the lesser-developed countries (LDC), according to a GSK scientist.

Pharma Action crude heparin plant due to open next week

28-Oct-2014 By Gareth Macdonald

A plant being set up by Pharma Action and meat supplier Toennies will produce 15 tonnes of 100% traceable crude heparin a year.

Starting debate: EMA says rules on API materials need clarification

23-Oct-2014 By Gareth Macdonald

Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.

NEWS FROM CPHI

The key to market exclusivity? Forget molecules, patent your tests

21-Oct-2014 By Fiona BARRY

Makers of branded drugs are finding ways to extend their marketing authorisation by patenting not only molecules, but patient screening methods and ways of proving bioequivalence.

News from edqm 50th anniversary conference

IPEC calls for inclusion of excipient compound monographs in Ph. Eur.

14-Oct-2014 By Gareth Macdonald

'Excipient compound' monographs should be included in the European Pharmacopoeia according to IPEC, which argues they would help manufacturers and promote acceptance of the standards outside Europe.

News from CPhI

DSM cuts out China's ATS-8 intermediate middlemen with enzyme-made statin APIs

14-Oct-2014 By Gareth Macdonald

Royal DSM has launched a statin API it claims is made using a green production method that reduces reliance on intermediate suppliers.

News from EDQM 50th anniversary conference

Drug complexity will change how Big Pharma uses Ph. Eur. says Pfizer expert

13-Oct-2014 By Gareth Macdonald

Growing drug complexity will soon make the European pharmacopoeia’s general chapters more valuable to innovative drugmakers than individual monographs according to Pfizer quality and compendial affairs expert, Graham Cook.