Small-Molecule APIs

Saneca Pharma is making significant investment in its API capabilities to support client demand for smaller batch sizes and streamlined scale-up.

Sound process understanding and having effective controls in place are crucial in ensuring that consistent product quality is obtained during API manufacturing.

API and drug product manufacturer changes name to align with parent company.

Dalton Pharma Services completed an expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.

CDMO Alcami adds HPAPI capacity and cryogenic capabilities to its Wisconsin facility.

Enzymatic catalysis offers pharma manufacturers a way to implement the Principles of Green Chemistry.

Recent chiral advances demonstrate promise for API synthesis.

Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.

Application of flow chemistry for small-molecule API synthesis continues to expand thanks to research efforts.

AMRI’s acquisition of Euticals expands its API development and manufacturing business.

Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies.

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.

A global API marketplace increases the burden of supply chain monitoring for drug companies.

Unsafe material may remain in the US supply chain, according to a March 29th letter to FDA Commissioner Califf

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

Gauging the adequate level and type of screening is the challenge when identifying relevant crystalline forms.

Hazardous reagents can simplify processes and provide higher yields and purities.

The chemical distribution industry has formed an international chemical trade association to address global issues.

Sustainable harvesting combined with CMO expertise helped Centroflora CMS ensure supply continuity after it acquired Boehringer Ingelheim's non-captive API phytochemicals portfolio.

Planned expansion at Onyx Scientific add laboratories, GMP suites, and storage space.

Andrew Badrot, founder and CEO of Centroflora CMS, discussed the acquisition and technical transfer of Boehringer Ingelheim’s (BI) non-captive phytochemical API portfolio with Pharmaceutical Technology.

FDA issued a warning letter to Zhejiang Hisun Pharmaceutical Co., Ltd., as a result of inspections that took place on March 2–7, 2015 at the Taizhou City, Zhejiang Province, API manufacturing facility.

Nanoscale catalysts and engineered nanoparticles may have a big impact on small-molecule pharmaceuticals.

FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.

BASF and Sumitomo Chemical explore in vitro system for chemical safety evaluation.

A strong API market is expected in 2016 despite fewer new drug approvals.

The ReactoMate Datum controlled lab reactor system accommodates a range of vessel sizes.

Ash Stevens has received FDA’s approval to manufacture Takeda’s multiple myeloma drug, ixazomib, at its facility in Riverview, Michigan.

BASF’s new multi-product amines plant in Ludwigshafen, Germany meets growing demand for amines in various applications, including pharmaceuticals.

The Transform hydrate-able film from Lubrizol LifeSciences is compatible with a range of APIs.