Pharmaceutical

Alembic Pharmaceuticals Ltd. has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dasatinib Tablets in multiple strengths. This marks a significant milestone for the Indian drugmaker, granting it entry into the U.S. market for a high-value oncology medicine used in the treatment of chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia (ALL). The approval reinforces Alembic’s growing presence in complex generics and regulated markets, with the U.S.

Glenmark Pharmaceuticals, a leading global pharmaceutical company, has launched its latest therapeutic product in the United States — Sodium Bicarbonate Tablets, USP — used in the treatment of metabolic acidosis. The launch strengthens the company’s position in the U.S. generics market, expanding its footprint in the nephrology and metabolic care segments. Glenmark’s introduction of this drug underscores its continued focus on broadening access to affordable healthcare while enhancing its presence across high-demand therapeutic categories.

India’s pharmaceutical and healthcare industry experienced a remarkable resurgence in the third quarter of 2025, recording USD 3.5 billion (approximately Rs. 29,000 crore) in deal value across 72 transactions. The period marked a strong rebound driven by mergers and acquisitions (M&A), private equity participation, and a series of high-value public market offerings.

Indian pharmaceutical major Lupin Ltd. has announced the launch of a generic version of Ravicti (glycerol phenylbutyrate) oral liquid in the United States for the treatment of urea cycle disorders (UCDs), a rare genetic condition affecting nitrogen elimination. The product, launched after securing approval from the U.S. Food and Drug Administration (FDA), represents another milestone in Lupin’s strategy to strengthen its presence in the U.S. generics and specialty care markets.

Global pharmaceutical giant Lilly has partnered with Indian healthcare leader Cipla to distribute the diabetes medication Yurpeak across India. The collaboration is poised to enhance access to innovative treatments for patients managing type 2 diabetes, reflecting a growing trend of strategic alliances between multinational and domestic pharmaceutical companies.

In a significant development within the pharmaceutical industry, Indian drugmakers Glenmark Pharmaceuticals and Dr. Reddy's Laboratories have initiated product recalls in the United States due to manufacturing issues, as reported by the U.S. Food and Drug Administration (USFDA). These actions underscore the ongoing challenges faced by global pharmaceutical companies in maintaining stringent quality control standards across diverse manufacturing facilities.

Natco Pharma has announced the acquisition of a significant equity stake in South Africa-based Adcock Ingram, marking a strategic step to expand its global presence and diversify its pharmaceutical portfolio. The investment aims to strengthen Natco’s footprint in international markets, particularly in Africa, while leveraging Adcock Ingram’s established distribution network and product lines. The acquisition aligns with Natco’s long-term growth strategy of targeting high-potential emerging markets and therapeutic segments.

Pharmaceutical giants Dr. Reddy’s Laboratories and Zydus Lifesciences have initiated voluntary recalls of select drug batches in the United States following notifications from the US Food and Drug Administration (USFDA). The recalls pertain to concerns over quality control and compliance with manufacturing standards, underscoring the regulator’s commitment to patient safety. Affected products include widely used generic medications distributed through multiple channels.

The BSE Sensex surged 329 points on robust buying momentum led by the pharmaceutical and banking sectors, reflecting investor optimism amid stable macroeconomic indicators. Market participants were encouraged by strong corporate earnings and renewed buying interest in mid- and large-cap stocks. Pharma stocks saw broad-based gains on expectations of healthy domestic demand and export opportunities, while banking shares benefited from improved credit growth projections and positive policy signals.

Biocon Pharma, a wholly owned subsidiary of Biocon Ltd., has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg. Developed in partnership with Carnegie Pharmaceuticals LLC, this generic antibacterial medication is indicated for reducing the risk of overt hepatic encephalopathy (HE) recurrence and treating irritable bowel syndrome with diarrhea (IBS-D) in adults. While the approval signifies compliance with regulatory standards, the product cannot be marketed in the U.S.