Excipients, raw materials and intermediates

Univercells ‘heralds a new era in vaccine production’

15-Jan-2019 By Maggie Lynch

After a low cost of manufacturing goal was achieved by a consortium for the development of a bioproduction system for vaccines, Univercells will launch its NevoLine system.

Akorn’s sterile plant receives US FDA warning letter

15-Jan-2019 By Maggie Lynch

Akorn received a warning letter from the FDA on January 4, relating to the inspection of its manufacturing facility in Decatur, Illinois, in April and May 2018.

Lupin recalls 42 lots of antibiotic after contaminate found in vials

14-Jan-2019 By Maggie Lynch

Lupin Pharmaceuticals voluntarily recalling lots of Ceftriaxone for Injection after rubber flecks were found in vials.

Roquette buys majority stake in India-based excipient manufacturer

17-Dec-2018 By Maggie Lynch

Roquette has purchased a majority stake in excipient manufacturer Crest Cellose, in an aim to increase its footprint in India’s generic pharmaceutical market.

Biovation invests in equipment able to create any tablet on the market

04-Dec-2018 By Maggie Lynch

Biovation expands its technology portfolio with all-encompassing tableting equipment to grow its production capacity and change specifications ‘on the fly’.

Five further countries join EMA-FDA mutual recognition pact

03-Dec-2018 By Ben Hargreaves

Inspections of manufacturing facilities undertaken by Belgium, Denmark, Finland, Latvia and Estonia will be recognised as valid by the US FDA.

WuXi STA aims to ‘add one API plant every year’, says VP

03-Dec-2018 By Ben Hargreaves

STA Pharmaceutical sees building out its own manufacturing infrastructure as a stronger growth plan compared to pursuing acquisitions.

Q&A

An easy pill to swallow: Colorcon tech targets the old, young, and pill-fatigued

26-Nov-2018 By Flora Southey

Swallowability is a recognised and growing patient problem, according to Colorcon’s general manager of film coatings, Kelly Boyer.

Pharma Integrates

Five technologies that could disrupt pharma manufacturing

23-Nov-2018 By Ben Hargreaves

Pharma production is ‘too conservative’ and needs to ‘be bolder’ in adopting nascent technologies, or be left behind by new models, suggested one MD.

Europe suspends use of Mylan’s Hyderabad-made valsartan

20-Nov-2018 By Flora Southey

EU authorities have detected NDEA in some batches of Mylan’s valsartan, manufactured in Hyderabad, India.

Public-private engage on climate change, same needs to happen for AMR, says DSM

12-Nov-2018 By Ben Hargreaves

Antimicrobial resistance is a global public health threat that both public and private organisations are struggling to combat.

US FDA hits Akorn with second Form 483 this year

08-Nov-2018 By Ben Hargreaves

Akorn’s Somerset facility becomes it second to require remediation action, following the issuance of a US Form 483.

AZ divests over $1bn worth of assets in one week

06-Nov-2018 By Maggie Lynch & Ben Hargreaves

AstraZeneca sold two drugs to Grünenthal for $700m and, a week later, divested a further three drugs to Covis for $350m.

SPI Pharma promises ‘fewer failures and higher yield’ with Mannogem XL

30-Oct-2018 By Ben Hargreaves

SPI Pharma has launched Mannogem XL mannitol for the production of various forms of tablets, which the firm says enhances productivity compared to compendial mannitol.

CPhI Worldwide

Brexit only a UK concern? Think again, says NSF director

19-Oct-2018 By Ben Hargreaves

As negotiations continue and discussions on ‘hard Brexit’ outcomes build, few have considered the impact on European industry, one organisation suggests.