Manufacturing

Opella is honoring its commitment to maintaining production volumes, investment levels, and jobs at its French plants by spending €40m to upgrade two sites in the country.

In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.

Pharmaceutical manufacturers encouraged FDA to consider including expansions and modifications of existing US facilities in PreCheck program.

A series of research papers recently published by the Global Self-Care Federation indicate that industry will need to be pragmatic about alternatives to PVC in medicine blister packs.

Amphastar plans three- to five-year expansion to quadruple production capacity for its US manufacturing operations at its Rancho Cucamonga, CA, headquarters. Primatene Mist Q2 sales reached $22.88m from $22.86m a year ago.

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

The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.

HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.

Bayer is investing $52m in its Lerma, Mexico manufacturing site, which the firm said will enable it to increase production of key OTC brands like Aspirin and Alka-Seltzer from 100m to 140m units by 2030.

Perrigo's retail customers are expecting real "net zero" progress from consumer health manufacturers, which is in turn driving the firm's sustainability ambitions and expectations from their own suppliers, Perrigo’s UK ethical compliance lead Isobel Gay tells HBW Insight in this exclusive interview.

Stada will ship a wide range of consumer healthcare products from its new Romanian production facility, into which the German firm has invested over €70m.

Although FDA concluded OTC oral phenylephrine is ineffective as a nasal decongestant in doses up to highest studied level, federal preemption precludes challenges to agency’s regulation of labeling for phenylephrine and other Rx and OTC drugs, according to recent decision in New York federal court.

FDA tobacco programs chief emphasizes moving smokers to lower risk alternatives and NIDA executive encourages proposals for e-cigarettes as nicotine replacement treatments. FDA also seizes $76m in unauthorized e-cigarettes.

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.

UK pharma also reaches agreement in principle, subject to DoJ approval, to pay $70m to resolve a whistleblower complaint filed by Valisure, the testing lab which in 2019 raised concerns about a potential link between the use of drugs containing ranitidine, a histamine-2 blocker, and cancer.

NDAs for additional OTC products containing acetaminophen and/or NSAIDs and indicated for use by children between 2 and less than 12 years old would trigger compliance by application sponsors with the act passed in 2003 to address lack of pediatric use information in drug labeling.

Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.

After launching Retaine MGD Advanced, OcuSoft says a release by Bruder Healthcare referenced Retaine MGD trademark and statements from a previous OcuSoft announcement about the original product attributed to an optometrist. B+L, Rohto brand and homeopathic firm Relief Products also make US OTC eye care space moves.

Jessica Spence joins as North American president while CFO Dan Sullivan becomes COO and Francesca Weissman, finance and business strategy SVP, adds CFO to her title in latest executive office changes by the marketer of brands including Schick men's and women’s shaving, Playtex, Stayfree, Carefree and o.b. feminine care and Banana Boat and Hawaiian Tropic sun care.

Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”