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Headlines > All Ingredients News

API supplier issues again cause FDA to reject Pozen drug candidates

18-Dec-2014 - For the second time the US FDA has rejected two versions of Pozen’s investigational drug candidate because of issues with a supplier’s foreign manufacturing facility.

News in brief

US FDA issues Form 483 to Hovione API facility in Portugal

18-Dec-2014 - The US FDA’s pre-approval inspection at Hovione’s API plant in Loures, Portugal, covering two NDA filings, resulted in a Form 483 with three inspectional observations. 

IPEC-Americas aims to make drug excipient users TUPP aware

15-Dec-2014 - 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.

AstraZeneca shutting asthma drug plant as pipeline shifts to biologics

12-Dec-2014 - AstraZeneca has continued the Big Pharma trend away from small molecule blockbusters and towards a biologics-heavy pipeline, announcing the closure of its Pulmicort facility in Massachusetts.

Sun closes in on Ranbaxy deal with CCI approval

10-Dec-2014 - The Competition Commission of India (CCI) has approved Sun Pharma’s $3.2bn acquisition of Ranbaxy.

Foreign investment in UK drugmaking down; ABPI tasks ex-GSK exec with reversing trend

10-Dec-2014 - An ex-GSK staffer charged with winning manufacturing investments for the UK says fostering innovation and “fiscal attractiveness” are vital.

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

10-Dec-2014 - 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.

From CPHI India 2014

Indian manufacturing problems spur growth... for testing companies

03-Dec-2014 - SGS has doubled testing capacity at its Mumbai facility, explaining that Indian API makers’ failure to invest in quality has been good for business.

Johnson Matthey acquires API capacity in Scotland

03-Dec-2014 - Johnson Matthey has completed its acquisition of API and pharmaceutical intermediate manufacturing capacity in Scotland. 

EMA seeking drugmaker feedback on cyclodextrin and propylene glycol labelling plan

03-Dec-2014 - The EMA has called for feedback on plans to require drugmakers to state whether their drugs contain solubility-enhancing cyclodextrin excipients.

Live from CPhI India

02-Dec-2014 - [View the story "Live from CPHI India" on Storify]

Dr Reddy's API plant receives USFDA 483 with nine observations

27-Nov-2014 - Dr Reddy’s says an API plant in India is unlikely to be subject to further regulatory enforcement after receiving a US FDA 483 with nine observations.

Chinese excipient market set to more than double by 2017

26-Nov-2014 - 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.

Johnson Matthey: APIs down but Sigma-Aldrich acq could bring opportunities

24-Nov-2014 - The acquisition of Sigma-Aldrich by Merck KGaA could provide some opportunities for Johnson Matthey, the fine chemical company says as it reports a flat first half 2014/15.

BASF sells Norway plant, focuses on pharma grade omega-3 products

24-Nov-2014 - BASF says the supply of API to GSK and other pharma customers will not be affected by the divestment of an omega-3 production plant in Norway.

Do laws hindering umbrella-wielding assassins also hurt Pharma?

19-Nov-2014 - The US Government has asked drugmakers and fine chemicals firms if laws designed to stop the proliferation of chemical weapons are hurting legitimate business.

Indian API manufacturer earns FDA warning letter due to cGMP violations

12-Nov-2014 - Cadila Pharmaceuticals was cited by the US FDA for failing to respond appropriately and to correct issues related to customer complaints.

API shipment delays, New Mexico site issues hamper AMRI Q3 earnings

11-Nov-2014 - Power interruptions and remediation work at AMRI’s Albuquerque, New Mexico facility, as well as unexpected delays to API shipments have driven down the company’s Q3 profits.

Pork Belies: Will traceability regs see China lose dominance of global heparin market?

10-Nov-2014 - Heparin production may be moving back to Europe according to the EFCG, which cited the opening of Pharma Action’s processing plant as an indication that API buyers value quality and compliance throughout the supply chain.

Golden spear: a thorn in Big Pharma’s ED business in China?

04-Nov-2014 - A generic version of Viagra launched in China contains the same amount of sildenafil citrate for a fraction of the price according to manufacturer Guangzhou Baiyuanshan Pharmaceutical Holdings (GBPH).

Warburg Pincus buys 32% stake in Laurus citing ARVs and global opportunities

03-Nov-2014 - Warburg Pincus has bought a 32% stake in Indian API maker Laurus Labs Private Limited citing the ARV drug ingredients market and international opportunities as drivers.

India cuts stability data reqs for API firms seeking docs to ship to EU

30-Oct-2014 - India has relaxed stability data requirements for API manufacturers seeking “written confirmation of quality” certificates needed to ship to the EU.

Pharma Action crude heparin plant due to open next week

28-Oct-2014 - A plant being set up by Pharma Action and meat supplier Toennies will produce 15 tonnes of 100% traceable crude heparin a year.

Superbug-driven surge in polymyxin demand prompts EMA to reassess safety info

27-Oct-2014 - A superbug-fuelled resurgence of polymyxin antibiotics has prompted the European Medicines Agency (EMA) to re-examine safety warnings for the side effect heavy anti-infectives

Starting debate: EMA says rules on API materials need clarification

23-Oct-2014 - 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.

Spotlight

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

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

A company developing a pharmaceutical chewing gum containing cannabinoids extracted from marijuana has announced plans to build...

Two INDs or not two INDs? Unanswered questions in China draft MRCT guide

Two INDs or not two INDs? Unanswered questions in China draft MRCT guide

Drugmakers that include China in multi-regional trials will need to submit dossiers filed elsewhere for review, open...

Advanced aspirin aspirations ailing? Sanofi and Pozen terminate deal

Advanced aspirin aspirations ailing? Sanofi and Pozen terminate deal

Sanofi and Pozen have dissolved a $35m (Eur28m) ‘advanced aspirin’ partnership less than a month before the...

Want to relocate to Asia? What pharma recruiters really look for

Want to relocate to Asia? What pharma recruiters really look for

Singaporean companies are looking for scientists, while China and India need execs – but don’t count on...

Chinese excipient market set to more than double by 2017

Chinese excipient market set to more than double by 2017

With more than 90 excipient manufacturers in China dedicated to the pharma industry, the country expects its...

BASF sells Norway plant, focuses on pharma grade omega-3 products

BASF sells Norway plant, focuses on pharma grade omega-3 products

BASF says the supply of API to GSK and other pharma customers will not be affected by...

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