Recent reports from the US health regulator unveil that pharmaceutical leaders Cipla and Glenmark are withdrawing products from the American market due to manufacturing discrepancies. The US Food and Drug Administration (USFDA) Enforcement Report highlights the recall initiated by Cipla’s New Jersey-based subsidiary, involving 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, manufactured at the Indore SEZ plant. These medications play a pivotal role in managing lung diseases like asthma, chronic bronchitis, and emphysema.
Complaints regarding a “short fill” issue prompted Cipla USA’s recall action, with reports of insufficient volume in respules and liquid seepage in intact pouches, as noted by the USFDA. Similarly, Glenmark Pharma’s US branch is recalling 3,264 bottles of Diltiazem Hydrochloride extended-release capsules, intended for hypertension treatment, due to “failed dissolution specifications.”
Both recalls, initiated in March and April 2024 respectively, underscore the importance of stringent quality control measures in pharmaceutical manufacturing. These events, categorized as Class II recalls by the USFDA, signify situations where product use may result in temporary or medically reversible adverse health effects.
India stands as a global leader in generic medicine production, accounting for approximately 20% of the world’s generic supply across 60 therapeutic categories. The nation’s pharmaceutical exports span over 200 countries, with key markets including Japan, Australia, Western Europe, and notably, the United States. India boasts the highest number of USFDA-compliant companies operating outside the US, reflecting its commitment to international quality standards in pharmaceutical manufacturing.
