1. USFDA clearance - Unit 1 and US market access - Unit 1 at Kazipally received an EIR with VAI status from the USFDA on 15th July 2025, confirming successful closure of the inspection. This unlocks the regulated US generics market, the world's largest, for the company's own API portfolio and contract manufacturing pipeline.
2. ANVISA clearance and Brazil entry - Unit 1 was successfully inspected by ANVISA from 22-26 September 2025, clearing the facility for the Brazilian market. Brazil is the largest pharmaceutical market in South America and this clearance opens a gateway into the broader Latin American region, adding a new regulated revenue stream.
3. Mahi Drugs USFDA clearance and commercialisation - The Mahi Drugs subsidiary was inspected by the USFDA in January 2025 with zero observations and is scheduled to begin commercialisation of its US DMF filings in FY26. This doubles the group's US-compliant manufacturing footprint just as the first DMFs convert to orders.
4. Orphan drug and niche API collaboration with HRV Global - On 21st January 2026, Haleos signed a strategic development and GMP manufacturing collaboration with HRV Global Life Sciences targeting orphan drug and niche therapeutic APIs for regulated and semi-regulated markets. The partnership combines Haleos's USFDA-GMP manufacturing with HRV's market access, targeting complex, high-value APIs in underserved segments across the US, EU, and other regulated markets.
5. New API production line - Unit 1 - A new API production line at Unit 1 was completed and is expected to become operational in the latter half of FY26, alongside renovation of a major production block. This adds immediate manufacturing capacity at the company's main USFDA and ANVISA-cleared site, removing a throughput bottleneck as new regulated-market orders ramp.
6. New API production line - Mahi Drugs - A new API line is planned at Mahi Drugs, expected operational by FY27, adding to the existing 2 API lines and 4 intermediate blocks with 213 KL total capacity. The expansion increases capacity at a site that is already USFDA-cleared with zero observations, ready to absorb new DMF-linked commercial orders.
7. New product pipeline and contract manufacturing tie-ups - The company plans to add more than 5 new APIs across SMS Life and Mahi Drugs and is initiating new contract manufacturing projects at both sites, supported by tie-ups with leading pharmaceutical partners. These projects fill the newly added and cleared production lines with revenue-generating molecules, converting regulatory clearances into commercial output.