Ingredients

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.

Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke

“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.

SafeBridge Consultants reports on the status of nine companies in the Potent Compound Safety Certification Program.

Investment group Ardian will acquire the fine chemicals business activities of DPx Holdings B.V.

The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.

AMRI expands its API portfolio and European presence through acquisition of Gadea’s Crystal Pharma Group.

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable the manufacture of multiple recombinant antibodies in a single batch culture.

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.

FDA, Congress, and early adopters look to speed up the use of continuous API manufacturing.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

Novasep's new antibody drug conjugate facility at its site in Le Mans, France will be commissioned in 2016.

The International Conference on Harmonization finalizes Q&A document on APIs.

BPTF seeks changes in performance goals and fee payment schedule in GDUFA renegotiations.

Safer reagents and reaction conditions are making many hazardous transformations possible.

Merus and Selexis will combine technology platforms to produce colorectal cancer combination therapy.

The dinner will be held on Oct. 14, 2015 during CPhI Worldwide, at the Prado Museum in Madrid.

Supply chain consortium establishes a working group to address quality problems in India.

FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.

An integrated pilot plant tests heteronucleation and continuous crystallization.

Recipharm makes a strategic investment in Synthonics and partners in development of novel compounds.

New legislation and changes in policy at FDA are leading to better control of the API supply chain.

A consensus-based standard issued by NSF International incorporates regulatory and industry requirements into a single standard for the manufacturing and distribution of pharmaceutical excipients.

NSF's consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.

Analytical technologies must accurately identify and measure the critical material attributes of APIs and excipients.

Ionic liquid technologies offer a new way to improve bioavailability.

Protecting workers, patients, and the environment requires advanced technologies.

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

It is vital that companies involved in the manufacturing and handling of cytotoxic drugs ensure that staff are given the highest possible levels of protection.

Resolution technologies remain crucial for commercial-scale chiral API production.