Ingredients

Axplora made waves with a recent announcement that the API specialist’s total investments for 2025 would exceed €100m. Anant Barbadikar, co-president of the firm’s PharmaZell business unit, explains how the firm’s strategy is evolving and why he believes the future of pharma remains small-molecule.

Teva has ended exclusive talks to sell its active pharmaceutical ingredients arm after failing to reach terms that aligned with its strategic and shareholder interests, but plans to relaunch the process as shifting geopolitical and market conditions renew buyer interest.

Sandoz’s CEO used the firm’s latest results call to highlight “trade distortion” in the pencillins market as a result of US tariffs, urging European authorities to take action to reduce the region’s “geopolitical exposure” and safeguard the long-term sustainability of European-produced penicillins.

FDA rejects NPAs arguments for clarity on when it recognizes start of investigational new drug programs and what constitutes “substantial clinical investigations” for an IND. Clock starts after FDA met twice-extended deadline to provide answers to NPA’s questions in a 2023 petition.

Teva has indicated that it is closer than ever to an agreement to finally sell its TAPI active pharmaceutical ingredients business. However, a deal is not a certainty just yet, as “issues remain” around the divestment.

Attorney Jonathan Emord says federal court’s grant of standing for Alliance for Natural Health USA and Meditrend to challenge FDA’s safety concerns about homeopathic drugs leaves open a door to continue arguing the agency violated multiple regulations by imposing NDA requirements for homeopathics.

FDA’s fourth approval in past two months for color derived from natural sources to use in foods is Gardenia Blue Interest Group’s color additive petition for gardenia blue. Lycored launches StellarYellow and C Clear as alternatives for synthetic dyes yellow Nos. 5 and 6 and OrangeOvation C Clear for

Health Subcommittee will discuss reauthorizing OMUFA during a hearing on how to “maintain and improve” the public health workforce and rural health as well as access to OTC medicines.

Chinese API exports to the US fell by 24% year-on-year to $255m in May, when the US and China called a truce in a previously escalating trade war.

Modifications to forms FDA 3500, for voluntary reporting by healthcare professionals, and 3500A, for mandatory reporting by manufacturers, marketers or facilities, include limiting changing gender question to sex and asking for only male or female answer.

Trade group ready to work hand-in-hand with agency and other supplement industry stakeholders on potential regulatory changes or improvements, says president and CEO Steve Mister. “None of them are upsetting the basic balance of things that DSHEA was attempting to do, but there are things with 30 years that we've identified that need to be kind of fixed.”

Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.