Suven Life Sciences has completed a US FDA renewal inspection at its Pashamylaram-based facility, which manufactures and supplies APIs, intermediates, and formulations.
A new method for determining the crystal structures of organic salts – which make up 40% of all APIs – could “greatly speed up” the drug development process, say researchers.
Cambrex has completed construction and validation of a new $3.2m, 11,000 square foot analytical laboratory at the former PharmaCore facility in High Point, NC.
Demand for a protein produced from a marine mollusk used as a carrier molecule in therapeutic vaccines has driven Stellar Biotech to expand a facility in LA.
Ferring Pharmaceuticals is buying Rebiotix and says its lead candidate has the potential to be the first human microbiome product approved anywhere in the world.
The active ingredient for Nichi-Iko’s diabetic neuropathy drug will be the first of a number of APIs to be supplied from Eisai’s facility in Vizag, India.
Novartis will sell its stake in a consumer healthcare joint venture to partner GSK and plans to invest the $13bn into its core pharmaceutical businesses.
The race to buy Pfizer’s OTC business – including Advil painkillers and Centrum vitamins – may have collapsed after both GlaxoSmithKline and Reckitt Benckiser officially walked away from the auction within days of each other.
IPEC Federation and PDA will publish a technical report in 2019 to provide drugmakers guidelines on how to implement risk assessment challenges of excipient supply.
AMPAC Fine Chemicals will boost Noramco Inc.’s supply of active pharmaceutical ingredients and intermediates to make abuse prevention and attention deficit disorder treatments, and cannabinoids.
The Danish drugmaker says it will take responsibility for commercial manufacturing after acquiring Parkinson’s disease candidate foliglurax in a deal worth up to €905m ($1.1bn).
CDMO Ardena has purchased active pharmaceutical ingredient and nanomedicine maker ChemConnection, as part of an acquisition strategy focused on development services.
Partnering with CMOs makes sense for emerging biotechs, says Ardelyx exec James Kanter, who relies on networking and clear communication guidelines to manage third-party relationships.
Indena says industry’s recognition of the high quality of Italian-made ingredients has driven investments in an HPAPI kilolab and a multi-purpose pilot plant near Milan.
Axim says its proprietary methods to extract and microencapsulate cannabinoid molecules make purer active pharmaceutical ingredients than traditional methods.
Reckitt Benckiser Group says it will be disciplined in its M&A strategy but remains silent on speculation it is buying Pfizer’s consumer healthcare business.
The US State Patent and Trademark Office has granted Teewinot Life Science Corporation its second patent this year covering biosynthetic cannabinoid production methods.
AstraZeneca says its hyperkalaemia candidate ZS-9 is back on track for approval after manufacturing issues at its Texas facility resulted in regulatory delays.
Kadam Exports Private has received a statement of non-compliance with GMP after the Danish Medicines Agency found manufacturing deficiencies at its facility in Gujarat.
Rephine says its online Quality Assurance database transforms the lengthy active pharmaceutical ingredient (API) pre-selection process to just a couple of clicks.
Scientists say a modified plant extract traditionally used as an arrow poison in eastern Africa could inhibit sperm cells’ ability to swim, and lead to the development of a male contraceptive pill.
Radiopharmaceuticals firm Telix Pharmaceuticals Limited has established a subsidiary in Japan to support clinical development and manufacturing activities.
A natural substance found in stinging nettles and ants repeatedly attacks cancer within cells, say scientists developing low-dose alternatives to current chemotherapy drugs.
Investment firm LeBaronBrown Llc has acquired American International Chemical Inc (AIC), a distributor of ingredients for the pharmaceutical sector and other industries.
Fresenius Kabi says drug ingredients made at an Indian plant hit with a US FDA warning letter meet quality specifications and has reiterated that tests were halted for technical reasons.
