Excipients, raw materials and intermediates

FDA's Woodcock details national security risks of global supply chains

07-Nov-2019 By Nick Taylor

FDA’s Janet Woodcock testifies to Congress about the potential risks to US national security of the pharmaceutical industry’s reliance on Chinese imports.

GSK and AZ on continuous manufacturing platform ‘grand challenge’

14-Oct-2019 By Vassia Barba

A consortium between CPI and the University of Strathclyde aims to create a direct compression platform for continuous manufacturing of oral solid dosage drugs.

The five potential sources of nitrosamine contamination

02-Oct-2019 By Ben Hargreaves

With nitrosamines back in the headlines due to the recent discovery of contaminants in ranitidine, the EMA releases the five potential causes of the impurities plaguing the industry.

LBB to supply Meggle’s excipients in the US market

05-Sep-2019 By Vassia Barba

LBB takes on the marketing and distribution of Meggle’s lactose-based excipients for direct compression and inhalation in the US market.

Analysis finds bulk of warnings delivered to Indian and Chinese drugmakers

30-Aug-2019 By Ben Hargreaves

The US market is dependent upon API and generic drugs produced in India and China, yet these countries also received the majority of warning letters issued by the US FDA.

Pharmaceutical excipients market to hit $9.8bn by 2025

28-Aug-2019 By Vassia Barba

Bolstered by manufacturing advancements, the global revenues of the pharmaceutical excipients market are expected to grow at a CAGR of 5.8% in the coming years.

Switzerland upgrades tests to boost detection of sartan impurities

09-Aug-2019 By Nick Taylor

The Swiss Agency for Therapeutic Products revises the test it uses to assess whether sartan medicines are contaminated with nitrosamines.

Is ‘lack of control’ in supply chains the root cause of API impurities?

07-Aug-2019 By Maggie Lynch

API recalls have sparked discussion on the development of impurities during manufacturing and the ways in which risks can be mitigated, according to an industry expert.

Croda plans life science investment after big quarter for excipient unit

06-Aug-2019 By Nick Taylor

Croda plans investments in life science business after high-purity excipient delivery system business drives 24% jump in healthcare sales.

LGM expands its services for section 503B APIs

15-Jul-2019 By Vassia Barba

LGM expands its service offerings to further support companies that supply APIs to compounding pharmacies under the FDA’s 503B section.

FDA warns repackers for cGMP violations on opioids

08-Jul-2019 By Vassia Barba

B&B, Asclemed and Spectrum receive warnings from the FDA regarding issues in the supply chain of APIs that ‘pose a real threat to public health’.

Novartis rejects suggestion of supplying chemicals to Syria

28-Jun-2019 By Vassia Barba

Novartis says it did not export substances potentially used as chemical weapons to Syria, distancing itself from Brenntag exports.

‘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.