Shilpa Medicare is a pharmaceutical company that makes the active ingredients inside medicines and the finished drugs themselves, spanning simple chemical pills all the way to living-cell-based therapies. It started in 1987 in Raichur, Karnataka, as a small antibiotic maker and has spent over 35 years climbing the complexity ladder, moving from basic drug ingredients into high-potency cancer drugs, injectables, biologics, and now antibody-drug conjugates (a kind of smart missile that links a cancer-killing chemical to a guided antibody). The recurring approach is to target niches with high barriers to entry-molecules that are hard to make, require specialised containment, or combine technologies few Indian rivals possess-and then use that know-how to attract global innovators who need a partner to develop and manufacture their drugs. # Business segments Two engines of roughly equal weight, built on the same manufacturing backbone - an active-ingredient business that supplies the world and feeds a formulations business that turns those ingredients into finished drugs, with a cross-cutting CDMO capability that serves both. ## 1. Active pharmaceutical ingredients and CDMO: the molecule factory **It makes the chemical and biological building blocks of drugs - from high-potency cancer compounds to peptides and polymers - and runs a specialty contract development arm for global innovator programmes, all from one subsidiary.** - **One in three of the top cancer molecules** - the company claims a leadership position with roughly 30% global market share for its top five oncology APIs, a position built on being the first in India to invest in contained manufacturing for these highly toxic compounds. - **Two plants, over 1,000 kilolitres of reactor space** - the Raichur facilities house 21 manufacturing blocks (9 for oncology, 12 for non-oncology) with batch sizes ranging from 125 grams for a potent cancer drug to 2,000 kilograms for a high-volume non-oncology product, all approved by regulators from the US FDA to Japan's PMDA. - **The CDMO arm is a partner, not just a supplier** - it has over 25 active programmes for global innovators, including three in late-stage Phase III trials, and in FY26 launched its first US new chemical entity programme for a big pharma partner while commissioning a dedicated block for a kidney-disease drug expected to receive US approval. - **Peptides and polymers are the new growth layers** - a dedicated large-scale peptide facility is being commissioned to target the top three global peptide molecules, including GLP-1 drugs, while the polymer division has already supplied a proof-of-concept ophthalmic polymer and received repeat orders from a multinational client. - **It feeds the group's own formulations** - the API business supplies the captive demand of the finished-drugs vertical, so margin that would go to an outside supplier stays inside the group. ## 2. Formulations and novel drug delivery: the finished-drug engine **It turns active ingredients into complex finished medicines - oral films that dissolve on the tongue, patches that deliver drugs through the skin, and ready-to-use cancer injectables - and licenses them to partners in over 80 countries.** - **Licensing is the business model** - the company develops a dossier (the regulatory package proving a drug is safe and equivalent), then out-licenses it to a European end customer who markets the product under their own brand, generating licensing income that forms a substantial portion of the segment. - **A pipeline of hard-to-copy products** - three 505(b)(2) products (modified versions of existing drugs) are in development, including a Parkinson's patch that received European marketing authorisation and completed USFDA submission with approval expected in FY27, and a novel long-acting injection for chemotherapy-induced nausea that posted positive Phase III results in India. - **Its first own new drug is already on the market** - Nor Ursodeoxycholic acid, a first-in-class therapy for fatty liver disease (which affects roughly one in four people globally), was launched in India under the brand Noduca™ and is being readied for US and European studies. - **Europe is the breakout region** - the European formulation business delivered over INR 200 crores in FY26, growing more than 100% year-on-year, driven by a B2B license-and-supply model and launches like the first generic of the cancer drug Nilotinib in the EU. ## 3. Biologics and biosimilars: the living-medicine bet **It makes biologic drugs - complex proteins grown in living cells rather than synthesised in chemical vats - including copies of blockbuster cancer and autoimmune therapies, plus wholly novel biological entities, from an integrated campus in Dharwad.** - **A single facility from cell to syringe** - the Dharwad plant runs mammalian cell cultures in 4,000 litres of bioreactor capacity and a microbial suite of 1,000 litres, with an in-house filling line that can handle 80 pre-filled syringes per minute, all under EU GMP approval. - **Biosimilars chasing billion-dollar markets** - the portfolio includes copies of Adalimumab (already approved in India and Morocco), the eye-disease drug Aflibercept (a roughly USD 12 billion global market, with Phase III nearing completion), and the cancer immunotherapy Nivolumab, for which a co-development deal with Finland's Orion Corporation was signed in mid-2026 to target Europe. - **Recombinant human albumin is the flagship novel entity** - this is a lab-grown alternative to blood-plasma-derived albumin, produced in yeast to eliminate any risk of viral contamination, with a dedicated plant in Kadechur and a Phase I trial successfully completed; Orion Corporation has already signed on as the European commercialisation partner. - **Two novel biologics are entering the clinic** - one is a fully human antibody against a new immune checkpoint protein, developed with a Swiss partner and carrying US Orphan Drug Designation for two rare blood disorders; the other is an inhaled live biotherapeutic for chronic lung disease, partnered with a US biotech in which Shilpa invested USD 2 million. ## 4. Antibody-drug conjugates: the smart-missile platform **It combines the group's chemical and biological skills to build antibody-drug conjugates - a guided therapy that links a potent cancer-killing chemical to an antibody that seeks out tumour cells - with fully in-house manufacturing of all three components.** - **A dedicated GMP facility was commissioned in mid-2026** - the Dharwad ADC suite is designed to meet US FDA and EMA standards and makes Shilpa one of the very few Indian companies with end-to-end ADC drug-substance manufacturing under one roof, from payload synthesis through to final purification. - **Payloads are already being sold externally** - one payload was supplied to a big pharma company, which completed registration batches using it, meaning Shilpa's ADC chemistry is already embedded in a partner's regulatory filing. # CDMO platform **A cross-cutting contract development and manufacturing engine that stitches together the group's small-molecule, peptide, biologic, and ADC capabilities into a single "clone-to-vial" offering for global innovators.** - **One partner, one integrated programme** - the relationship with Unicycive Therapeutics covers both API and formulation development for a kidney-disease drug, illustrating how a client can get everything from one company rather than coordinating multiple vendors. - **25-plus active programmes across the spectrum** - the CDMO pipeline spans pre-clinical development through to commercial manufacturing, with three candidates in Phase III and roughly one new customer added every quarter in FY25. # Group structure and partners **A parent listed entity with wholly owned subsidiaries housing each major vertical, plus a web of strategic partnerships that give the group access to markets and novel science without building everything from scratch.** - **The API business sits in a dedicated subsidiary** - Shilpa Pharma Lifesciences Limited, a 100% subsidiary, has held the API operations since the slump sale of July 2022, isolating the ingredient business for focused growth. - **Biologics is split across two subsidiaries** - Shilpa Biologicals Pvt Ltd runs the biosimilars, novel biologics, and CDMO operations from Dharwad, while Shilpa Biocare Private Limited is dedicated to the recombinant human albumin programme at its Kadechur plant. - **International subsidiaries handle regional commercialisation** - Shilpa Pharma Inc. covers North America; Koanaa Healthcare Spain S.L. runs the European B2B business from near Barcelona; and Koanaa International FZ-LLC in the UAE manages Africa and the Middle East, including a new joint venture in Saudi Arabia to build a local manufacturing facility. - **Partnerships fill the pipeline and the markets** - Orion Corporation (Finland) is the European partner for both recombinant albumin and the Nivolumab biosimilar; Amneal Pharmaceuticals commercialises ready-to-use oncology injectables in the US; and a Swiss biotech, mAbTree, co-developed the novel immuno-oncology antibody that carries US Orphan Drug Designation.