GLENMARK PHARMACEUTICALS EUROPE LIMITED

Glenmark launched Lacosamide oral solution, bioequivalent to Vimpat, treating partial-onset and generalized tonic-clonic seizures. Vimpat sales reached $57 million (Oct 2024). Glenmark, with 201 US-approved products and 51 pending ANDAs, aims for affordable alternatives. Q2 FY25 net profit was Rs 354.49 crore, up from a loss of Rs 180.3 crore in Q2 FY24. Shares rose 0.83% to Rs 1,529.80.

Aurobindo Pharma, Glenmark, and Zydus are recalling products in the US due to manufacturing issues, according to the USFDA. Aurobindo is recalling over 1 lakh bottles of Cinacalcet tablets, Glenmark is recalling 90,000 bottles of Diltiazem Hydrochloride extended-release capsules, and Zydus is recalling 4,404 packs of Esomeprazole Magnesium for Delayed-Release Oral Suspension due to labelling errors.

The generic pharmaceuticals market was valued at USD 424.98 billion in 2024 and is projected to reach USD 874.63 billion by 2033, driven by cost-effective medications, rising chronic disease prevalence, government support, and advancements in manufacturing technologies.

Glenmark Pharmaceuticals launched Travoprost Ophthalmic Solution USP, 0.004%, used to reduce eye pressure in glaucoma or high eye pressure patients. The product is bioequivalent to Travatan Ophthalmic Solution USP, 0.004% by Sandoz, Inc. Glenmark's portfolio expansion includes 200 U.S. market products and 51 pending ANDAs with the USFDA. The company reported a net profit of ₹354.4 crore for Q2 FY25.

Diabetic Peripheral Neuropathy market to surge due to increasing prevalence and awareness, with multiple-stage pipeline products revolutionizing market dynamics. Key companies include Grünenthal, Averitas Pharma, Daiichi Sankyo, Vertex Pharmaceuticals, Helixmith, and Lexicon Pharmaceuticals. Emerging therapies such as QUTENZA (capsaicin) and TARLIGE (mirogabalin besylate) are expected to drive market growth.

Life Sciences Regulatory & Compliance team tracks key developments in pharmaceuticals, biologics, medical devices, diagnostics, and laboratory testing, including monitoring the BIOSECURE Act, final LDT rule, and FDA guidance on clinical trials. The team also follows FDA, EMA, and MHRA approvals, commercial requirements, coverage and reimbursement issues, compliance, fraud and abuse, and privacy regulations affecting patient data.

HFCL partners with GA-ASI for UAS sub-systems, Dreamfolks Services addresses disruption, Sterling and Wilson Renewable Energy CFO resigns, Ugro Capital postpones board meeting, Aster DM Healthcare leases land for new hospital, Vodafone Idea signs $3.6 billion network deal, ONGC Videsh secures gas deal in Azerbaijan, USFDA inspects Glenmark Pharmaceuticals with no observations, Ramco Cements expands capacity, BHEL awarded NTPC contract, Reliance Industries extends call money payment deadline, USFDA inspects Aarti Drugs with Form 483 observations, Tata Steel commissions India’s largest blast furnace, Avalon Technologies CFO resigns, USFDA inspects Dr Reddy’s Laboratories with zero observations, HDFC Bank approves HDB Financial Services IPO, Bharat Forge enters renewable energy agreement, Signature Global CFO resigns, JM Financial reappoints and appoints MDs, Adani Total Gas secures international financing, Godfrey Phillips India considers bonus shares, Mankind Pharma approves fund raising, Vanguard Group Inc buys stakes in various companies.

Biocon received 3 observations from USFDA after inspection of Bengaluru API facility. Aarti Drugs received 7 observations from USFDA after inspection of Tarapur API facility. Glenmark Pharmaceuticals received zero observations from USFDA after inspection of Aurangabad formulation facility.