Shilpa formulations revenue rises 71% in 1HFY27 as sales expand

Shilpa reported formulations revenue of Rs 407 crore in 1HFY27, up 71% from Rs 238 crore in 1HFY26, led by Europe at Rs 139 crore and the US at Rs 81 crore. The result combined regional portfolio sales, the domestic NorUDCA launch, new approvals and tender wins across rest-of-world markets.

What drove Shilpa’s formulations revenue growth in 1HFY27?

Shilpa’s reported growth came mainly from commercial formulations sales rather than licensing and services. Total formulations revenue rose by Rs 169 crore between 1HFY26 and 1HFY27, while licensing and services increased by Rs 1 crore to Rs 65 crore. Shilpa said first-half revenue increased by more than 70% year on year across key markets.

The quarterly result extended that momentum. Revenue was Rs 210 crore in 2QFY27, compared with Rs 139 crore in 2QFY26 and Rs 198 crore in 1QFY27. Shilpa said revenue excluding licensing income rose about 87% year on year in 2QFY27, when it had three commercialized complex or 505(b)(2) projects and more than five in development. A 505(b)(2) application is a US route that can partly rely on existing evidence.

Which markets contributed most to Shilpa’s formulation sales?

Europe delivered Shilpa’s largest regional increase, adding Rs 66 crore to reach Rs 139 crore in 1HFY27. Its 2QFY27 revenue was Rs 82 crore, compared with Rs 40 crore in 2QFY26, and Shilpa attributed the increase to portfolio expansion and market penetration.

The US added Rs 56 crore year on year, reaching Rs 81 crore in 1HFY27 from Rs 25 crore. Quarterly US sales were Rs 35 crore in 2QFY27, below Rs 45 crore in 1QFY27 but above Rs 20 crore in 2QFY26. Shilpa attributed the annual quarterly growth to commercial traction in its niche 505(b)(2) portfolio.

Domestic revenue rose to Rs 44 crore in 1HFY27 from Rs 16 crore in 1HFY26, with Rs 20 crore recorded in 2QFY27 against Rs 9 crore a year earlier. Shilpa linked domestic growth to the NorUDCA launch. Revenue in rest-of-world, or RoW, markets increased to Rs 78 crore from Rs 60 crore, driven largely by new product approvals and tender wins.

What formulation launches is Shilpa preparing?

Shilpa has launched NorUDCA as Noduca for non-alcoholic fatty liver disease, or NAFLD, in India. The presentation describes Shilpa as the first company globally to obtain approval for NorUDCA in NAFLD and says it has marketing partnerships with three large companies in India. Shilpa also established a dedicated medical representative team and is applying for additional indications through global trials.

The closest disclosed overseas launch is a rotigotine transdermal patch for Parkinson’s disease. It has final marketing authorization from the European Medicines Agency and is being prepared for launch in 2HFY27; Shilpa’s US Food and Drug Administration submission is complete, with approval expected in FY28. Tadalafil oral film has EU approval via the hybrid route, pan-European commercialization partners and a planned FY28 launch.

Shilpa’s topical lotion SMLTOP09 received Phase III approval from India’s Drugs Controller General of India and began a pivotal trial in January 2026, with completion targeted by 2HFY27. It has also started a global Phase III study for an EU submission. For its Alzheimer’s patch projects, SMLTDP012 is advancing to pivotal submission studies in 2HFY27, while SMLTDP018 completed exhibit batches in 2QFY27 and is scheduled to begin a pivotal study in 3QFY27.

Which injectable, oral and GLP-1 products have near-term milestones?

Shilpa plans an India launch of its long-acting ondansetron injection, SMLINJ011, in 2HFY27, subject to a manufacturing licence. The product has follow-on positive Phase III results in India and Subject Expert Committee approval from the Central Drugs Standard Control Organisation. Global clinical development is under way for the US, EU and RoW markets.

Nab-paclitaxel had its EU dossier filed in 2QFY27, with a US filing planned in 2HFY27 after exhibit batches were completed; RoW filings are under way. Enzalutamide has a completed EU filing and commercialization partner, with a US filing planned in 2HFY27. Abiraterone, a once-daily 1 gram tablet, also has a completed EU filing, while pivotal studies continue for a US filing.

For SMLPFS020 semaglutide, Shilpa has completed exhibit batches and is undertaking stability studies. The company says the program is fully backward integrated through synthetic and semi-synthetic routes and that partnering discussions cover markets outside the US. The presentation does not disclose a filing or launch date for semaglutide.

How large is Shilpa’s formulation filing base?

Shilpa reported 867 cumulative formulation filings across the US, EU, Canada and RoW, comprising 480 approved and 387 pending applications. RoW accounted for 724 filings, including 382 approved and 342 pending, while the EU had 100 filings, of which 73 were approved and 27 pending.

The US portfolio contained 32 abbreviated new drug application, or ANDA, and new drug application, or NDA, filings, including 17 approved or tentatively approved and 15 pending. Shilpa received more than 30 new formulation approvals in 1HFY27. Unit IV at Jadcherla also received EU good manufacturing practice certification, although the presentation does not assign a revenue contribution or timing to individual approvals.

Conclusion

Shilpa’s first-half formulations expansion was broad-based: Europe, the US and domestic sales together added Rs 150 crore year on year, while licensing and services were nearly flat. The disclosed mix of established regional portfolios, the Noduca launch, RoW approvals and tender wins indicates that the reported increase was not attributed to a single product event.

The next milestones disclosed by Shilpa include a European rotigotine launch in 2HFY27, an Indian ondansetron launch subject to a manufacturing licence, and US filings for nab-paclitaxel and enzalutamide in 2HFY27. Progress in pivotal patch studies, semaglutide stability work and commercialization of more than 30 approvals received in 1HFY27 are further matters to watch.