Excipients, raw materials and intermediates

‘Significant benefit’ to drug delivery excipient leads to deal

13-Jun-2019 By Ben Hargreaves

PeptiDream agrees a strategic partnership with PharmaIN to utilise its PGC delivery technology for its peptide discovery and development programs.

KD Pharma adds to omega-3 API production supply chain with UK site

04-Jun-2019 By Maggie Lynch

KD Pharma adds manufacturing site in Seal Sands, UK, to manufacture omega-3-based intermediates for use in API production.

Lonza to carve-out and trim down Specialty Ingredients business

03-Jun-2019 By Ben Hargreaves

Lonza announces that its Specialty Ingredients business will operate independently by ‘mid-2020’ and will cut away approximately 130 roles at the same time.

Novo Nordisk sees ‘growing interest in sustainability’ across industry

29-May-2019 By Ben Hargreaves

Although the industry may not be among the ‘frontrunners’, Novo Nordisk is seeing the benefits when it comes to recruitment and developing mutually beneficial partnerships, says director.

Directly compressible starch by Colorcon promises simpler tableting

21-May-2019 By Vassia Barba

Colorcon expands its portfolio of direct compression solutions, with the launch of StarTab, a tableting excipient based on starch.

Over 100 lots of losartan tablets recalled after NMBA detected

29-Apr-2019 By Maggie Lynch

Teva begins recall in the US of 35 lots of losartan tablets and Torrent expands its recall to include an additional 104 lots, after trace amounts of NMBA were discovered in both companies' products.

How to tackle a sticky issue

27-Mar-2019 By Ben Hargreaves

Sticking is one of the most common issues that is faced in the manufacture of tablets, and may become a more pressing issue once continuous manufacturing is broadly adopted, suggests I Holland’s R&D manager.

DEA license offers Cure hemp-based CBD manufacturing

21-Mar-2019 By Maggie Lynch

Cure Pharma expands its DEA license to include authorization to manufacture both cannabis plant extracts and CBD within the scope of its patent portfolio.

ACG expands in Latin American with announcement of its Brazilian capsule plant

18-Mar-2019 By Maggie Lynch

ACG announces plans to grow its Latin American presence with its newest capsule production plant in Brazil, as it continues to expand its facilities in Asia-Pacific and Europe.

Researchers call on manufacturers to provide excipient allergy info

18-Mar-2019 By Ben Hargreaves

A study carried out by MIT researchers has found that 93% of medications contain excipients with the potential to cause an allergic reaction.

Sartan issues continue as Macleods and Camber issue recalls

04-Mar-2019 By Maggie Lynch

Camber and Macleods voluntarily recall losartan tablets lots, after trace amounts of a possible carcinogen found in an API ingredient manufactured at the same third-party facility.

FDA’s draft guidance clears path for generic competition

19-Feb-2019 By Maggie Lynch

US FDA issues draft guidance for its competitive generic therapies pathway, providing drugmakers with clarity on the designation and calling on the industry for more generic competition.

‘Simply unacceptable’: FDA warns against illegitimate opioids

18-Feb-2019 By Maggie Lynch

The FDA issued a warning letter to McKesson for violations concerning a possible distribution of illegitimate opioid products while calling for action in securing the supply chain from illegitimate medications, especially opioids.

POLL

FDA seeks transparent relationship on manufacturing standards

15-Feb-2019 By Ben Hargreaves

US FDA is reaching out to the industry to agree upon ‘voluntary consensus standards’ to promote the development of drugs and reduce manufacturing cost.

Pfizer recalls valsartan drug after possible carcinogen present

11-Feb-2019 By Maggie Lynch

Pfizer Japan recalls its high blood pressure drug containing the API valsartan after possible carcinogenic impurities were found.

Quality standards at the heart of generic development

08-Feb-2019 By Maggie Lynch

Developing generics that receive approval is more efficient when quality and production standards exist, explains USP CEO.

UPDATE

Europe to ban sartan medicines with any level of contamination

04-Feb-2019 By Ben Hargreaves

The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.

Novo Nordisk selects ‘local presence’ for Asia-Pacific distribution

21-Jan-2019 By Maggie Lynch

Novo Nordisk Pharmatech selected DKSH to distribute its pharmaceutical grade compounds to the company’s growing customer base in the Asia-Pacific region.

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.

EMA places Zhejiang Huahai under ‘increased supervision’ over quality issues

17-Oct-2018 By Ben Hargreaves

The EMA has placed Zhejiang Huahai under supervision, after the firm produced valsartan medication contaminated by probable carcinogens.

eTheRNA guarantees mRNA supply with Belgian manufacturing site

11-Oct-2018 By Maggie Lynch

eTheRNA announced it will be opening a cGMP compliant mRNA manufacturing facility in Belgium, to increase production of its three mRNA encoding proteins.

CPhI Worldwide 2018

CPhI 2018: Dispatches from Madrid

11-Oct-2018 By Flora Southey

Following stints in Paris and Frankfurt, CPhI Worldwide has again set up in Madrid for three days of insight briefings, biopharmaceutical tracks and networking.

CPhI Worldwide 2018

Ashland launches film coating tech in response to ‘continuous' demand

09-Oct-2018 By Flora Southey

The Aquarius Genesis film coating system is specially designed for continuous manufacturing, but can also be applied to batch processes, says executive.

Continuous manufacturing: When will everyone be doing it?

05-Oct-2018 By Ben Hargreaves

The answer, according to consultant Emil Ciurczak, is in 10 years – at least, if generics manufacturers and CMOs want to be competitive.

Bosch to present oral solid dosage production device

03-Oct-2018 By Maggie Lynch

Bosch packaging technology will showcase its laboratory device for oral solid dosage forms, Xelum R&D for continuous manufacturing.

Cambrex cements North Carolina presence with buildings purchase

01-Oct-2018 By Maggie Lynch

Cambrex, a small molecule and API manufacturer, announced it will expand to establish a ‘center of excellence’ for process and development of its API clinical supply.

Evonik expands API and advanced intermediates manufacturing with €36m investment

26-Sep-2018 By Maggie Lynch

Evonik completed a €36m expansion of its contract manufacturing capabilities of API and advanced intermediates in the US and Europe.

EU-US mutual recognition extends with Portugal added to roster

24-Sep-2018 By Ben Hargreaves

With the US recognising Portugal’s ability to carry out GMP inspections, 15 countries are now part of the mutual recognition agreement between the EU and the US.

Chinese API producer refuses entry of EU inspectors

12-Sep-2018 By Ben Hargreaves

Jiangsu Yew Pharmaceutical outright refused permission for inspectors from Hungary to visit its site, resulting in the suspension of the company’s marketing authorisation.

UK gov’t guidance leaving too little time to adjust to ‘no deal’ Brexit?

10-Sep-2018 By Ben Hargreaves

IPT speaks to life sciences lawyer, Jane Summerfield, to interpret the recent guidance from the UK government in the event of a ‘no deal’ Brexit.

US FDA issues an alert on life-threatening porcine therapy API

07-Sep-2018 By Maggie Lynch

The FDA issued an alert that Sichuan Friendly Pharmaceuticals has recalled its porcine thyroid API.

Researchers target rapid changes to downstream continuous manufacturing

29-May-2018 By Nick Taylor

Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.

INTERPHEX 2018

Excipient makers want to be the ‘first second’ in novel ingredient development, say execs

17-May-2018 By Flora Southey

An improved relationship between drugmakers and excipient suppliers could help drive development in the novel inactive ingredient sector, says industry expert.

Ardena continues M&A strategy with CMO buy

14-May-2018 By Flora Southey

CDMO Ardena has added drug product capabilities with the purchase of active pharmaceutical ingredient and excipient-focused Syntagon.

News in Brief

Suven passes US FDA inspection, secures CNS product patents

09-May-2018 By Melissa Fassbender

Suven Life Sciences has completed a US FDA renewal inspection at its Pashamylaram-based facility, which manufactures and supplies APIs, intermediates, and formulations.

Codexis outfits CDMO with biocatalyst tech in new partnership model

03-May-2018 By Melissa Fassbender

Codexis is setting up Porton Pharma Solutions with its biocatalyst technology as part of a strategic collaboration aimed at liberating potential cost reductions of up to 20%, says CEO.