### **Overview** Shilpa Medicare Ltd. is a vertically integrated, global pharmaceutical company headquartered in Raichur, Karnataka, India. Established in 1987, the company has evolved into a leading player in the development and manufacturing of **Active Pharmaceutical Ingredients (APIs), Finished Dosage Forms (FDFs), biologics, and Contract Development and Manufacturing Services (CDMO)**. With a strong focus on **oncology, peptides, polymers, and novel drug delivery systems (NDDS)**, Shilpa positions itself as a differentiated, technology-driven CDMO offering end-to-end solutions across small and large molecules, from preclinical to commercial scale. --- ### **Business Segments & Verticals** 1. **APIs (Oncology & Non-Oncology)** - Dominant segment contributing significantly to revenue. - Holds ~30% global market share in top oncology APIs. - Flagship products: **Nilotinib, Azacitidine, Pemetrexed, Methotrexate, Axitinib**. - Focus on non-infringing synthesis, cost leadership, and import substitution. - Key non-oncology APIs: **Ursodeoxycholic Acid (UDCA), Tranexamic Acid, Ambroxol**. - Expanding capacity: UDCA (10 MT/month), Tranexamic Acid (25 MT/month), Nilotinib, Azacitidine, and Palbociclib. 2. **Formulations (FDF)** - Achieved strong growth: FDF revenue ~16% YoY, base business grew 67% YoY (H1 FY26). - Differentiated products in oncology: **Pemetrexed RTU, Bortezomib RTU**. - First launch of **NorUrsodeoxycholic Acid (NorUDCA)**, first-in-class therapy for **NAFLD**, in India (Q3 FY26), supported by marketing partnerships. - Ready-to-Use (RTU) injectables eliminate reconstitution, improve patient compliance. - Oral Disintegrating Films (ODFs) and transdermal patches are key NDDS platforms. 3. **Biologics** - One of the few Indian CDMOs offering **integrated biologics development and manufacturing**, including **ADCs, biosimilars, and novel biologics (NBEs)**. - Flagship asset: **Recombinant Human Albumin (rHA)**, designated a **New Biological Entity (NBE)** in India. - Strategic out-licensing with **Orion Corporation** for European commercialization of rHA. - Phase III trials for rHA planned in India and EU (FY26). - **ADC platform**: Offers one-stop integrated CDMO services for Antibody-Drug Conjugates, a high-growth area. - Partnerships: **mAbTree Biologics (Switzerland), Alveolus Bio**. 4. **CDMO Services** - Offers end-to-end CMC solutions across **APIs, biologics, and formulations**. - Among few Indian CDMOs with capabilities in both **small and large molecules, biologics, and ADCs**. - Growing client base: **10+ global innovator clients**, including major pharma and biotechs. - CDMO revenue grew 47% YoY to ₹6,193 lakhs in FY25. - Clients span preclinical to Phase III, with multiple commercialization projects underway. --- ### **Strategic R&D & Innovation** - Operates **5 R&D centers** in India (Raichur, Ahmedabad, Bengaluru, Hyderabad, Dharwad) with 400+ scientists. - Over **550 patent applications** filed across APIs, formulations, and biologics. - Key innovation areas: - **GLP-1 agonists**: Liraglutide, Semaglutide, Tirzepatide (API and formulations). - **Peptides**: High-purity, long-chain, multicyclic peptides; CEPs secured for **Desmopressin and Octreotide**. - **Polymers**: Specialty and bio-polymers; sole Indian supplier for a $4M US project. - **AI/ML-enabled drug discovery** via **Sravathi AI** for route prediction, impurity identification, and lead optimization. - **Flow chemistry** and **bipolar membrane technology** for green, high-yield processes. --- ### **Notable Products & Pipeline (Nov 2025)** - **NorUrsodeoxycholic Acid (NorUDCA):** - Global first NCE for **NAFLD**. - Launched in India (Q3 FY26), plans for global expansion. - CDSCO approved; supported by partnerships with 3 domestic companies. - **Pemetrexed & Bortezomib RTU:** - US launches driving FDF growth. - No reconstitution needed – improved safety and patient adherence. - Gaining market share quarter-over-quarter. - **Recombinant Human Albumin (rHA):** - Phase III trials initiated in India and EU (FY26). - Filed US DMF (excipient and therapeutic), EMA scientific advice received. - Large-scale fermentation facility (Kadechur, 200+ KL capacity) operational. - **Antibody-Drug Conjugates (ADCs):** - Developing a dedicated facility; first ADC candidate entering human studies in FY26. - Partnerships with global innovators for exclusive manufacturing. - **Semaglutide & Liraglutide:** - Process validation ongoing; US DMF filing scheduled for FY26. - Fully automated peptide manufacturing facility in development. - **Aflibercept Biosimilar:** - Phase III ongoing (India), targeting **~$9B market** in ophthalmology (AMD, DME). --- ### **Capacity Expansion & Manufacturing** - **API Facilities:** - 2 large-scale plants in Raichur (1,000+ KL annual capacity). - Dedicated OEL-4 containment for high-potency oncology APIs. - **Formulations:** - **Dabaspet facility (Karnataka)**: Approved by USFDA, EDQM, TGA, MHRA, WHO-GMP. - 50M ODF & 30M transdermal patch capacity annually. - EIR received for Unit VI (transdermal patches). - **Biologics:** - **Dharwad facility (Shilpa Biologicals Pvt. Ltd.)**: - Single-use bioreactors (up to 2,000L). - Capable of microbial and mammalian expression. - EU GMP-approved; one of few in India with integrated biologics ADC capabilities. - **Large-scale rHA facility at Kadechur**: Commissioned in FY26. - **New Investments:** - Automated **peptide manufacturing facility** (commissioning next FY). - Dedicated **OLC (oxylanthanum carbonate) plant** for Unicycive Therapeutics (Q3 FY26). --- ### **Commercial & Regulatory Highlights** - **Global Approvals**: Products approved in **US, EU, Canada, Australia, Saudi Arabia, Japan, Brazil, South Africa, and Russia**. - **Recent Approvals & Launches**: - **Rivaroxaban ODF**: Final MA expected, commercialization in FY27. - **Rotigotine patch**: EU launch expected H2 FY26; US trials in final stages. - **Aflibercept biosimilar**: Regulatory filing planned in EU/US post-Phase III. - **Licensing Model**: - Low-capital, high-margin strategy. - Partnerships with **Amneal, Sun Pharma, Orion, Unicycive, mAbTree**. - Revenue via upfront fees, milestones, supply contracts, and profit sharing. --- ### **Strategic Collaborations** - **Unicycive Therapeutics**: Exclusive global supplier for **Oxylanthanum Carbonate (OLC)** under 505(b)(2); expected commercialization revenue in H2 FY26. - **Orion Corporation**: Exclusive EU rights to **Recombinant Human Albumin**; milestone payments secured. - **mAbTree Biologics (Switzerland)**: Co-developing **novel immuno-oncology biologic**, entering Phase I in FY26. - **Alveolus Bio**: Partnership to co-develop COPD-focused biologic. - **Koanna Healthcare (Spain)**: JV to strengthen EU B2B licensing and supply. --- ### **Growth Strategy (FY26 Focus)** 1. **Capacity Expansion**: Scale production of UDCA, Tranexamic Acid, Ambroxol, and oncology APIs. 2. **R&D Acceleration**: Advance complex generics, biosimilars, peptides, and NDDS. 3. **Operational Excellence**: Leverage **AI, flow chemistry, automation**, and green manufacturing. 4. **Global Expansion**: Increase regulated market footprint in US, EU, ROW. 5. **Monetization**: Drive revenue from CDMO projects, out-licensing, and proprietary product launches. --- ### **Financial & Market Position** - FY25 Revenue: **₹1,310 Crores** (+13% YoY); EBITDA: **₹340 Crores** (+35% YoY). - Strong order book with sustained growth expected from **NorUDCA, Pemetrexed, Bortezomib, biologics CDMO, and polymer projects**. - Well-positioned in high-growth segments: ADCs, GLP-1, peptides, biosimilars, NDDS.