Aurobindo Pharma Ltd.

Amneal cautioned of a “reasonable probability” that particulate matter in the epidural space could damage the spinal cord or set off an epidural inflammatory process to meningitis. Particulate contamination has sparked the recalls of numerous injectable drugs over the years, with Amneal’s hospital med ropivacaine now the latest to fall victim to the trend.Amneal is recalling two lots of ropivacaine hydrocholoride injection on the risk that the anesthetic could contain inert “fibers” that leeched into the product from its IV bag, according to a notice on the FDA’s website.The recall, which covers a 500-mg/100-ml dose of the drug packaged in infusion bags, is specifically concerned with particulate contamination by the common thermoplastic polymer polypropylene.Patients could suffer serious side effects if the contaminated drug is delivered epidurally or inadvertently administered to the intrathecal space via the spinal canal, Amneal warned in its recall notice.The company cautioned of a “reasonable probability” that particulate matter in the epidural space could damage the spinal cord or set off an epidural inflammatory process to meningitis. When administered intrathecally, the particulates in the tainted drug also have the potential to cause inflammation and water on the brain, which can lead to embolization and organ damage.As of Friday, Amneal had not received any side effect or injury reports tied to the suspect drug batch. Ropivacaine is used as both regional anesthesia for surgery and as a tool for acute pain management in hospitals.Amneal’s product pull covers hospital meds shipped across the U.S. between April and November last year.Amneal triggered a separate recall last March when it pulled four batches of the antibacterial oral solution vancomycin hydrochloride, which is used to treat intestine and colon inflammation. At the time, the company noted that it may have “overfilled” certain bottles during a manual portion of the manufacturing process.That error could have led to patients receiving more of the medication than intended, putting them at risk of worsening kidney function, Amneal warned at the time.Particulate contamination, when bits of a drug’s packaging or components from the manufacturing process worm their way into the product itself, has sparked multiple recalls in recent years, often accompanied by warnings of serious potential complications for those who take the polluted meds. Last April, Aurobindo’s Eugia unit yanked one lot of injectable methocarbamol after a customer complaint flagged the presence of white particles in a product vial. And, a month before that, Endo’s Par Pharmaceutical recalled one batch of treprostinil injection over fears that silicone particles had made their way into certain vials.Injecting particulate matter can cause a range of side effects, from the aggravating but ultimately benign—like irritation at the injection site—to the severe, such as stroke or death, Par cautioned in its recall alert.

Trump's new Section 232 investigation, Leqembi's EU approval, and Kyowa Kirin's $118 million biologics plant made our news this week. The Trump administration is expected to announce tariffs on pharmaceuticals "in the next month or two," an official said. The European Commission has approved Eisai and Biogen's Leqembi in Alzheimer's disease. Kyowa Kirin has finished the build-out of a Japanese biologics plant. And more.1. Trump administration launches national security investigation into pharmaceuticals, paving way for tariffsIn short reprieve for pharma, commerce secretary says drug tariffs to come 'in the next month or two'The Trump administration has launched what’s known as a Section 232 investigation, looking into the national security effects of pharmaceutical imports. Findings from the probe could support tariffs on drugs, which Commerce Secretary Howard Lutnick said will come “in the next month or two.” The Indian Pharmaceutical Alliance warned that generic manufacturers, which are already operating on “razor-thin margins,” can’t bear large tariffs.2. Eisai, Biogen's Alzheimer's med Leqembi wins long-awaited European approvalAfter months of back and forth, Eisai and Biogen’s Leqembi has won the European Commission’s authorization in Alzheimer’s disease. The indication covers certain early-stage patients with mild cognitive impairment. In Europe, the drug's use is restricted to those who have one or no copies of the ApoE4 gene and who have amyloid beta plaques in their brain.3. As work on massive US plant continues, Kyowa Kirin wraps up construction of $118M biologics plant in JapanKyowa Kirin has finished the construction of a new drug substance manufacturing facility at its site in Takasaki, Japan. The 16.8 billion Japanese yen ($118 million) plant will be used to produce investigational biologics for early-stage development. The site also serves as a training facility to help fill Japan’s gap in experienced biopharma production engineers.4. Biocon Biologics lines up US Eylea biosim launch in '26 (Regulatory tracker)Biocon Biologics has reached a deal with Regeneron on the company’s Eylea biosimilar, Yesafili. Approved by the FDA last year, the interchangeable biosimilar can be launched in the U.S. in the second half of 2026 or earlier under certain conditions. Given the settlement, the two firms have moved to dismiss their pending litigations on the subject.5. Daiichi Sankyo inks RNA-targeted neurodegenerative disease deal with Wayfinder (release)Daiichi Sankyo has penned a collaboration with Wayfinder Biosciences to develop RNA-targeting small molecules for a neurodegeneration target. Seattle-based Wayfinder says its platform enables quantitative insights into the binding of small molecules to RNA and their selectivity and function. Financial details were not disclosed.6. Haleon takes full control of famed Chinese consumer health joint venture (Reuters)Haleon paid about 1.62 billion Chinese yuan ($220 million) to obtain the remaining 12% stake in the Chinese joint venture Tianjin TSKF Pharmaceutical. Formed in the 1980s by Smith, Kline & French and Tianjin Pharmaceutical, the consumer health firm marked one of the first foreign-backed drugmakers to enter China. The company is a household name with popular OTC brands such as the Fenbid line of ibuprofen products, and it generated 2024 revenue of 3.56 billion yuan ($490 million).Other News of Note:7. Aurobindo gets Form 483 scolding from FDA at North Carolina inhaler plant8. Daiichi Sankyo celebrates its roots and blooming future at DC cherry blossom festival9. After 5-year delay, CMG Pharma wins FDA nod for oral schizophrenia drug (Korea Biomedical Review)

Aurobindo Pharma has announced that the US Food and Drug Administration (USFDA) issued a Form 483 with 11 observations to its Raleigh plant in North Carolina, operated by its subsidiary Aurolife Pharma LLC. The inspection was conducted from March 24 to April 10, 2025. The observations are described as procedural and will be addressed through a comprehensive response within the required timeline, detailing corrective and preventive actions. Aurobindo emphasized its commitment to maintaining high-quality standards and stated that this development is not expected to impact current business operations or existing supplies from the facility. This regulatory update highlights the importance of compliance in pharmaceutical manufacturing, with Aurobindo affirming its dedication to meeting USFDA standards.