Alvogen, Inc.

Lupin is no stranger to recalls, and has at times even had to suspend production of U.S.-bound drugs at its plants. Mumbai's Lupin has issued a voluntary recall of 2,724 bottles of the tricyclic antidepressant clomiPRAMINE hydrochloride, which is used to treat obsessive-compulsive disorder (OCD) by boosting serotonin activity in the brain.Lupin’s product pull covers 25-mg capsules of the drug in 100-count bottles. The suspect batch, which was distributed across the U.S., was set to expire at the end of June, according to a recent FDA enforcement report. The manufacturer formally kicked off the recall on April 10.According to the FDA’s report, Lupin said the drug—manufactured at the company’s Baltimore, Maryland, production site—failed to meet impurities and degradation specifications during an 18-month stability study.The recall ranks as Class II, which means the FDA figures there is a low chance the issue could cause serious injuries or death. Lupin is no stranger to recalls, and has at times even had to suspend production of U.S.-bound drugs at its plants.In late November, Lupin recalled more than 600,000 bottles of the high blood pressure and heart failure drug ramipril due to the presence of an active pharmaceutical ingredient (API) that came from an unapproved vendor.Before that, the company in 2023 pulled two lots of birth control pills from U.S. shelves. The recall, which covered Tydemy tablets, also stemmed from out-of-specification stability testing results that led Lupin to fear the drugs might not be effective in preventing pregnancy.As for the manufacturing suspension at its troubled Tarapur facility in the Indian state of Maharashtra, the FDA in 2022 asked Lupin to alert it before resuming operations there with the intent to produce for the U.S. market. The restriction followed the receipt of a warning letter at that facility.Elsewhere, multiple other drugmakers have initiated recalls of their own in 2025.Glenmark pulled roughly 1.48 million bottles of the generic attention-deficit/hyperactivity disorder (ADHD) drug atomoxetine in early March, citing unacceptable levels of the possible carcinogen N-nitroso atomoxetine. Prior to that, ICU Medical in February recalled two lots of potassium chloride intravenous bags over labeling issues that could increase the chances of an accidental overdose. Potassium chloride solution is used to rapidly restore potassium levels in patients with hypokalemia.Meanwhile, Alvogen, Astellas Pharma and Endo have triggered 2025 recalls on pain meds, immunosuppressants and vasoconstrictors, respectively. 

Alvogen plans to fight a court decision that could significantly delay its ability to bring a generic version of Bausch Health’s Xifaxan to market, the company said. On Friday, its subsidiary Norwich Pharmaceuticals appealed a federal district court ruling that held the FDA was right to grant tentative, but not final, approval to the company’s rifaximin tablets for the treatment of irritable bowel syndrome with diarrhea. The FDA declined to grant final approval because Teva, the first applicant to file for a generic version, is eligible for 180 days of marketing exclusivity, according to the opinion. The decision marks the latest win for Bausch Health in its bid to delay generic competition to Xifaxan, a key product that accounted for almost $2 billion in US revenue in 2024. The court ruling, if it stands, could bar Alvogen from marketing its proposed generic until at least June 2028. “We will persist in advocating for the well-being of patients who have greatly benefited from sustained access to Xifaxan,” Bausch Health CEO Thomas Appio said in a statement last week. Alvogen is now appealing the case to the US Court of Appeals for the DC Circuit. A representative for the company didn’t immediately respond to a request for comment. The drugmaker had argued the FDA should have granted it final approval because Teva’s subsidiary Actavis forfeited its 180-day exclusivity period. Actavis hasn’t actively pursued or obtained approval to market rifaximin tablets, even though it applied about 10 years ago, Alvogen said. But in an opinion that was unsealed on Friday, the US District Court for the District of Columbia disagreed. “All tools of statutory interpretation point, like a compass, in one direction: Actavis has not forfeited its 180-day exclusivity under the failure-to-market provision,” the district court said. The FDA’s decision “comports with the clear text and structure” of the law and no forfeiture occurred because Actavis included the proper certifications in its application, the court said. Teva’s Actavis is barred under a settlement agreement from entering the generic rifaximin market until January 2028, unless another applicant obtains approval and comes to market, according to Alvogen. Alvogen “would stand to gain and maintain a significant larger share of the generic rifaximin market for IBS-D than if it launches as just one of several generic alternatives. Such loss of market share constitutes irreparable harm,” the company had alleged in its complaint.

Significantly increased quality and lower manufacturing costs for long template mRNAs SAN DIEGO, March 26, 2025 /PRNewswire/ -- Primrose Bio, Inc. ("Primrose"), a company developing proprietary therapeutic manufacturing technologies, announces the launch of Prima RNApols™ ExTend, an RNA polymerase engineered to significantly improve manufacturing of long-template mRNA vaccines and therapeutics, including mRNA medicines based on self-amplifying mRNAs. This enzyme shows improved performance, resulting in superior mRNA quality at a lower cost. Prima ExTend outperforms traditional T7 polymerase by generating higher-quality mRNA with lower dsRNA, eliminating a common challenge in mRNA manufacturing and enhancing downstream purification efficiency. Furthermore, Prima ExTend's transcription efficiency results in higher yield using lower amounts of key inputs, which can contribute to lower production costs. "Prima ExTend is a much-needed innovation for the production of long-template mRNA therapeutics, that often struggle with integrity and quality issues that add risk to these programs. Our new enzyme is an important advancement for drug developers and researchers seeking high-integrity, high-yield mRNA," said Helge Zieler, CEO. "This innovation underscores our commitment to providing leading technologies that support the manufacturing of the next generation of mRNA vaccines and therapeutics." Prima RNApols ExTend is available in an in vitro transcription kit for research use applications. GMP-grade Prima RNApols manufactured and released under ISO 13485:2016 certified quality systems are available for clinical and commercial mRNA manufacturing. For more information, please visit . About Primrose Bio, Inc. Primrose Bio is focused on developing and commercializing its integrated end-to-end technology platform for solving complex drug manufacturing and design challenges. Primrose major offerings include Prima RNApols™: improved enzymes for mRNA manufacturing; Pfenex Expression Technology®: a proprietary production system used in six approved products with up to 20x higher yields and unparalleled success in making complex proteins; and PeliCRM197®: a commercially validated CRM197 carrier protein used for conjugate vaccines. Several of the world's leading pharmaceutical companies use Primrose's technologies, including Merck, Jazz Pharmaceuticals, Alvogen, Serum Institute of India, Arcellx, Arcturus and others. For more information, please visit . SOURCE Primrose Bio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED