Rising API prices from China and feedstock disruptions amid the West Asia crisis are tightening cost pressures on India's pharma sector despite temporary inventory buffers
Currently, more than 95 per cent of Rubicon's revenue comes from the United States (US), where the company has built a generics and specialty portfolio
Govt urges pharma firms to cut import reliance, boost domestic production and diversify exports as data shows rising foreign value addition and heavy dependence on China and the US
Lupin says its US subsidiary will pay $30 million to Humana to settle antitrust claims, adding the amount has already been provided for and does not impact current financials
US tariffs on patented drugs may have limited immediate impact on India, but industry flags uncertainty as policy ties relief to pricing and manufacturing shifts
A government committee will evaluate sector-wise allocation of C3 and C4 streams for key sectors amid supply constraints and rising energy prices due to the West Asia crisis
Firms may shift to doctor outreach, CME programmes and patient support initiatives as CDSCO bars advertising of GLP-1 drugs ahead of semaglutide patent expiry
Ipca Labs hit a 52-week high of ₹1,624 on the BSE in Tuesday's intra-day trade amid heavy volumes and was seen inching towards its record high of ₹1,757.55 touched on January 3, 2025.
India and Uzbekistan have launched a policy-backed pharma-nutraceutical corridor to improve regulatory alignment, investment and market access for manufacturers targeting the $7-10 billion Eurasian he
Acutaas Chemicals management has revised revenue guidance upwards from 25 per cent to around 30 per cent growth for FY26.
In the past one month, Lupin has outperformed the market by soaring 6 per cent, as against 4.5 per cent decline in the BSE Sensex.
India's drug regulator is withdrawing export NOC requirements for SRA markets and easing other low-risk approvals, even as it strengthens oversight of manufacturing quality
Sanofi has expanded its Hyderabad Global Capability Centre, raising capacity to 4,500 employees and strengthening India's position as a key hub for R&D, AI, digital innovation
The pharmaceuticals department has invited stakeholder comments on proposed changes to the list of 350-plus medical devices exempt from GTE rules, with submissions open until February
India's pharmaceutical exports to the US are unlikely to see major tariff changes under the interim pact as Section 232 investigations continue, though medical devices may gain from better access
Pharma companies will no longer ne required to seek a test licence and may proceed with pharmaceutical development upon submitting an online intimation to CDSCO, except in certain cases, as part of broad simplication notified by the Union Health Ministry. Union Health Ministry has notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at simplifying regulatory processes, reducing approval timelines, and enabling faster conduct of clinical research and pharmaceutical development in the country. The amendment is line with the directions of Prime Minister Narendra Modi to reduce regulatory burden and promote Ease of Doing Business, the ministry sais Under the existing regulatory framework, pharmaceutical companies are required to obtain a test licence from the Central Drugs Standard Control Organization (CDSCO) for the manufacture of small quantities of drugs intended for examination, research, or analysis purposes. Through the notified amendments, thi
Strong domestic demand is set to lift pharma revenues by up to 11% in Q3FY26, though pressure from generic Revlimid in the US may limit profit growth
Granules India Ltd on Thursday said its arm Granules Pharmaceuticals, Inc has received tentative approval from the US health regulator for its generic amphetamine extended-release tablets indicated for treatment of attention deficit hyperactivity disorder, with eligibility of 180-day exclusivity. The tentative approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amphetamine extended-release tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg, Granules India Ltd said in a regulatory filing. These are the generic equivalent of DYANAVEL XR, it added. "The Granules ANDA has been determined to be eligible for 180-day exclusivity by the FDA, reinforcing its growing capabilities in developing and commercialising complex and differentiated generic products for the US market," the company said. The product is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and has an estimated market size of USD 41 ...
Granules India plans to raise up to ₹1,762 crore from promoter, and non-promoter groups through a mix of convertible warrants and preferential issue of equity shares.
Ilumya, a novel biologic treatment that selectively inhibits IL-23, has already established itself as a blockbuster drug internationally, with presence across 35 countries