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.
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.
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.
Lonza announces that its Specialty Ingredients business will operate independently by ‘mid-2020’ and will cut away approximately 130 roles at the same time.
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.
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.
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.
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 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.
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.
US FDA issues draft guidance for its competitive generic therapies pathway, providing drugmakers with clarity on the designation and calling on the industry for more generic competition.
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.
US FDA is reaching out to the industry to agree upon ‘voluntary consensus standards’ to promote the development of drugs and reduce manufacturing cost.
The EMA’s investigation into ‘sartan’ medicines has concluded, requiring companies to review processing procedures and prove products are without impurities.
Novo Nordisk Pharmatech selected DKSH to distribute its pharmaceutical grade compounds to the company’s growing customer base in the Asia-Pacific region.
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 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.
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 expands its technology portfolio with all-encompassing tableting equipment to grow its production capacity and change specifications ‘on the fly’.
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.
As negotiations continue and discussions on ‘hard Brexit’ outcomes build, few have considered the impact on European industry, one organisation suggests.
eTheRNA announced it will be opening a cGMP compliant mRNA manufacturing facility in Belgium, to increase production of its three mRNA encoding proteins.
Following stints in Paris and Frankfurt, CPhI Worldwide has again set up in Madrid for three days of insight briefings, biopharmaceutical tracks and networking.
The Aquarius Genesis film coating system is specially designed for continuous manufacturing, but can also be applied to batch processes, says executive.
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.