Small-Molecule APIs

Efficient syntheses are possible using multi-component and cross-dehydrogenative, heteroaromatic C-H silylation reactions.

Athenex will build two facilities for high-potency, oncology API ingredients in Chongqing, China.

Hovione is investing in specialized formulation capabilities, beginning with the acquisition of a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures, Portugal, the company announced on Oct. 19, 2015. This acquisition is a strategic investment to further boost development and manufacturing capabilities for both inhalation and oral dosage forms.

Grace and Formac Pharmaceuticals have announced SilSol 6035 Mesoporous Silica Gel, the first silica in the Grace silica-based drug delivery platform. The silica gel is the result of a multi-year collaboration between the companies.The platform was engineered to offer a new drug delivery option for APIs with poor aqueous solubility (BCS class 2 compounds), Grace reports and combines the company’s expertise in mesoporous silica gel and novel application methods to accelerate the screening and development of stable, amorphous-based systems.

Safer solid reagents and new coupling chemistry are important developments.

BASF completes sale of custom synthesis business and parts of its API business to Siegfried Holding.

Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.

Supersonic spray-drying process yields stable and soluble amorphous nanoparticles.

EMD Millipore, the Life Science business of Merck KGaA, introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials, which include excipients, process chemicals, and APIs.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

A study of recent inspection observations allows for baseline trending and continuous improvement. (The opinions expressed in this article do not necessarily reflect FDA’s position on the matter being discussed.)

More complex drug candidates require more specialized and selective chemistry.

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.

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

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

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

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.

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