Pharmaceutical

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

AstraZeneca Pharma India and Sun Pharmaceutical Industries have formed an exclusive brand partnership to promote and distribute SZC for hyperkalaemia treatment under separate brands

Eli Lilly invests $1B in India as Mounjaro succeeds, Hyderabad site to boost global supply and innovation

Tata Capital Healthcare Fund II has deployed nearly all of its $130 million corpus, benefiting 8.3 million people and driving job creation and gender diversity across India's healthcare ecosystem

Pfizer is suing over some unsolicited competition in its nearly $5 billion bid to buy the drugmaker Metsera. New York-based Pfizer said Friday after markets closed that it was suing Metsera and a third drugmaker, Denmark's Novo Nordisk, over a bid for Metsera that Novo announced Thursday. Novo said it planned to buy Metsera in a deal that could be worth up to $9 billion, and Metsera said the offer appeared to be superior to Pfizer's bid, which was announced in September. Metsera Inc has no products on the market, but it is developing potential oral and injectable treatments. That includes some potential treatments that could target lucrative fields for obesity and diabetes. Novo already has the treatments Wegovy and Ozempic on the market in those respective categories. Pfizer said the offer from Novo cannot be considered superior to its bid because it carries significant regulatory risk that makes it unlikely to be completed. Pfizer, which ended development of a potential pill to

Sharvil Patel takes over as President of IPA from Samir Mehta, with Glenn Saldanha appointed Vice President, as the industry navigates reforms and global challenges

The Trump administration has clarified that while these tariffs might not be enforced immediately, they are still in play and can be implemented in the near future

Vector Consulting Group study finds pharma firms spend up to ₹75 cr annually on IT systems, but 70% of digital projects fail due to adoption gaps and poor execution

Till 11:32 AM; as many as a combined 130 million equity shares representing 34 per cent of total equity of Sigachi changed hands on the NSE (112 million shares) and BSE (18 million shares).

GST Council meet outcome: GST on various medical apparatus and devices used for medical, surgical, dental or veterinary usage has been reduced to 5% from 12%

The pioneering Danish drugmaker was once the most valuable company in Europe, but analysts say a number of missteps reversed its fortunes

The global market for weight-loss drugs is estimated at $100 billion by the end of the decade