Excipients, raw materials and intermediates

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FDA’s draft guidance clears path for generic competition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US FDA issues draft guidance for its competitive generic therapies pathway, providing drugmakers with clarity on the designation and calling on the industry for more generic competition.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