### **Overview** Haleos Labs Limited (formerly SMS Lifesciences India Ltd.) is a leading Indian manufacturer specializing in Active Pharmaceutical Ingredients (APIs), intermediates, and contract manufacturing services. With operations since 1990, the company has evolved into a globally recognized player in the bulk drug sector, serving generic and innovator pharmaceutical companies across regulated and emerging markets. The company operates through manufacturing facilities in **Hyderabad (Kazipally – Unit I, Jeedimetla – Unit IV)** and **Visakhapatnam (Mahi Drugs)**, with a total installed capacity of **800 KL**. It is now progressing through a strategic transformation phase marked by expansion into new markets, technological advancement, and enhanced regulatory compliance. --- ### **Business Segments & Product Portfolio** - **Core Segment**: APIs and intermediates, including custom synthesis and contract manufacturing. - **Key Therapeutic Focus**: - Anti-ulcer (Gastrointestinal Acid Secretion – GAS): Major products include **Ranitidine HCl (35.04% of FY22 sales)** and **Famotidine**. - Anti-Erectile Dysfunction (EDF). - **Product Concentration**: Top 10 products accounted for **92% of revenue in FY22**, with continued focus on expanding this portfolio. - **Portfolio Expansion Plans**: - Introduction of **more than five new APIs** across SMS Life and Mahi Drugs (from Sep 2025). - Target to launch **3–8 new products annually**, including collaborations with **ChemWerth Inc.**, a U.S.-based full-service generic API company. --- ### **Regulatory Compliance & Market Access** Haleos Labs and its subsidiary Mahi Drugs have built a strong reputation for regulatory adherence: - **Certifications**: Facilities are approved by **USFDA**, **Japan PMDA**, **WHO GMP**, and undergoing review by **EDQM**. - **US Market Entry**: - **Mahi Drugs' Vizag facility** successfully passed a **USFDA inspection in February 2025** with only one procedural observation. - Plans to commence **commercialization of US Drug Master Files (USDMFs)** within the next 12 months, paving the way for U.S. market entry. - **Other Regulatory Milestones**: - **Kazipally Unit (Unit 1)** received **Voluntary Action Indicated (VAI)** status after USFDA inspection (May 2025). - Preparing for **ANVISA inspection (Sep 2025)**, which will open doors to Brazil and broader Latin American markets. - **DMF Filings**: Submitted **7 DMFs to USFDA** during FY2024–25 to support regulatory pathways for new products. --- ### **Manufacturing & Infrastructure Development** - **Installed Capacity**: - **Total**: 800 KL across all units. - **Hyderabad Units (Kazipally & Jeedimetla)**: Combined API/intermediate capacity of **65 KL** (as of Sep 2024), with ongoing expansions. - **Mahi Drugs (Visakhapatnam)**: **190 KL intermediate capacity** and two API lines, currently being upgraded for compliance with regulated markets. - **Capacities & Capabilities**: - Reactor temperature range: **-70°C to 220°C**; pressure up to **25 kg/cm²**. - Capable of **high-vacuum distillation (down to 0.1 Torr)**. - Experience in manufacturing across multiple human therapeutic categories. - **Expansion Projects (Sep 2025)**: - Renovation and expansion of a major production block at **Unit 1 (Kazipally)**. - A new **API production line** at Mahi Drugs scheduled to become operational by **2026–2027**, significantly increasing capacity. --- ### **Research & Development (R&D)** - **Facility**: DSIR-approved R&D center in **Sanath Nagar, Hyderabad**. - **Team**: - **72 R&D professionals as of March 2025**, including **two Ph.D. scientists** leading innovation initiatives. - Focus areas: **novel synthesis routes, process optimization, analytical method development, cost efficiency, and technology transfer**. - **Investment**: - **₹630 lakhs (~$7.5 million)** spent on R&D in FY2024–25, representing **2% of turnover**. - The R&D unit supports **commercial scale-up** and ensures competitive advantage in process robustness and regulatory readiness. --- ### **Commercial & Strategic Developments** - **Stable Core Revenues**: Strong demand for **Ranitidine and Famotidine**, despite global scrutiny on nitrosamine impurities (NDMA). - **Key Customer Relationships**: - Top 5 clients contributed **42.32% of sales in FY22**, down from 48.70% in FY21 — indicating improved diversification. - Long-term relationships averaging **17 years** with global players such as **Mylan, Sun Pharma, Cadila**, underscoring reliability and trust. - **Export Footprint (Jul 2025)**: - Major export destinations: **USA, China, Indonesia, Malaysia, Singapore, Spain, Brazil** — reflecting **diversified geographic reach**. - **Contract Manufacturing Growth**: - New projects initiated at SMS Life and Mahi Drugs to expand **custom synthesis and CMO services**, broadening revenue streams and client base. --- ### **Strategic Vision & Market Expansion** - **Short-Term Goals (2025–2027)**: - Strengthen presence in **U.S. and EU markets**. - Achieve commercial scale in **U.S. regulated market** via Mahi Drugs' USDMF filings. - Expand manufacturing capacity and improve operational efficiency. - **Long-Term Vision**: - Diversify product portfolio and reduce dependency on core APIs. - Enter **frontier markets** driven by rising healthcare access and demand for affordable generics. - Leverage partnerships and alliances (e.g., with ChemWerth Inc.) for co-development and faster regulatory entry. - The company is well-positioned to capitalize on the **global shift toward non-Chinese API suppliers**, focusing on **quality, compliance, sustainability, and EHS excellence**. --- ### **Leadership & Governance** - **Mr. T.V. Praveen, Executive Director**: - Aged 42, key leader with **over 16 years of pharma experience**. - Previously worked with **Deloitte (USA) and Cognizant**, advising major clients like **Pfizer and Johnson & Johnson**. - Joined SMS in 2008; played pivotal roles in **international expansion, demerger execution (2017), and acquisition of Mahi Drugs (2018)**. - Oversees **marketing, supply chain, R&D, finance, operations, and regulatory affairs**. - Holds **55.41%** of paid-up equity alongside immediate relatives — part of the **promoter group**. - **Mr. TVVSN Murthy, Vice Chairman & Joint Managing Director**: - Industry veteran with career beginning in 1981 at Standard Organics. - Co-promoted SMS Pharmaceuticals in 1990. - Instrumental in process innovations, notably reducing **Ranitidine synthesis from 7 to 4 steps**, enhancing efficiency. - Leads environment, health, safety (EHS), and energy-saving initiatives. --- ### **Awards & Recognition** - **India Pharma Award**: ‘Bulk Drug Company of the Year’ (2020). - **Outstanding Export Performance Award 2018–19** in the ‘All round-Rising Star’ category. - Recognition reflects the company’s **commitment to quality, export excellence, and innovation**.