Shilpa Medicare is a global pharmaceutical company delivering affordable, high-quality healthcare solutions through innovation, science, and integrated capabilities.
Shilpa Medicare Limited is an integrated Indian pharmaceutical company founded on 20 November 1987 in Raichur, Karnataka, by Vishnukant Chaturbhuj Bhutada. Originally incorporated as Shilpa Antibiotics Limited, the company today develops and manufactures oncology Active Pharmaceutical Ingredients, complex finished dosage forms, biosimilars, antibody-drug conjugates and recombinant human albumin, serving customers in more than 50 countries.
Our integrated capabilities span the entire pharmaceutical value chain — from early research and development to commercial-scale manufacturing — supported by world-class infrastructure, regulatory-compliant facilities, and a culture of scientific excellence.
Shilpa Medicare began in 1987 in Raichur, a district town in northern Karnataka far from India’s pharmaceutical clusters. The first commercial product, trimethoprim, was manufactured in November 1989. Nearly four decades later, the company operates across the full pharmaceutical value chain — from process chemistry and API manufacture, through complex formulation development, into biosimilars and antibody-drug conjugates.
The pattern in that history is consistent: Shilpa Medicare has repeatedly chosen the harder molecule. Antibacterials gave way to oncology APIs, which demanded containment engineering most Indian manufacturers did not then possess. Oncology APIs gave way to oncology finished dosage forms, which demanded sterile and high-potency capability. Those gave way to oral dissolving films, transdermal systems, peptides and biologics — each a step further from commodity manufacturing and closer to genuine scientific differentiation.
Business | Operating Entity | What It Delivers |
|---|---|---|
| Active Pharmaceutical Ingredients | Shilpa Pharma Lifesciences Limited | 70+ commercial APIs; oncology, non-oncology, peptides, polymers; ~1,160 KL reactor capacity across two Raichur sites |
| Finished Dosage Forms | Shilpa Medicare Limited | Oral solids, sterile injectables, oral dissolving films, transdermal patches, oral suspensions, topicals, novel drug delivery |
| Biologics | Shilpa Biologicals Private Limited | Biosimilars, monoclonal antibodies, antibody-drug conjugates, biologics CDMO; EU-GMP certified campus at Dharwad |
| Recombinant Proteins | Shilpa Biocare Private Limited | Animal-free recombinant human albumin; 200+ KL fermentation capacity at Kadechur |
| Contract Research & Development | FTF Pharma Private Limited | Formulation development, regulatory strategy, IP evaluation, bioequivalence studies |
| International Markets | Koanaa Healthcare group | Marketing authorisations, tenders and distribution in Europe, the UK, Spain and the MENA region |
Wholly owned. Holds the entire Active Pharmaceutical Ingredient business, including API Units I and II at Raichur, peptide and polymer capability, and specialty CDMO operations. Awarded the EcoVadis Gold Medal for sustainability performance in November 2025.
Wholly owned. Operates the biologics campus at Dharwad, Karnataka: biosimilars, monoclonal antibodies, antibody-drug conjugates and biologics CDMO services. EU-GMP certified following a February 2025 inspection closed with zero observations.
Wholly owned. Manufactures animal-free recombinant human albumin by yeast fermentation at Kadechur, Yadgir district, Karnataka, with 200+ KL fermentation capacity. Holds a 30.4% shareholding in Gate2Brain S.L., Barcelona.
Wholly owned, acquired in 2020. Contract research and formulation development at Sanand, Ahmedabad, Gujarat: novel dosage form development, regulatory strategy, intellectual property evaluation and bioequivalence studies.
The group's international front-end. Koanaa Healthcare GmbH (Austria), Koanaa Healthcare Ltd (United Kingdom), Koanaa Healthcare Spain S.L. and Koanaa International FZ LLC (UAE) hold marketing authorisations and manage distribution and tender business in their respective regions.
The group's United States commercial and regulatory office, based in Doylestown, Pennsylvania.
Partner | Region / Scope | Focus |
|---|---|---|
| Orion Corporation (Finland) | Europe | Exclusive European rights to recombinant human albumin; co-development and exclusive European supply of a nivolumab biosimilar |
| SteinCares | Latin America — 30+ countries | Exclusive biosimilar licensing, registration and distribution; manufacture from Dharwad |
| NXI Therapeutics AG (Switzerland) | Global | Long-term CMC development, scale-up, GMP clinical supply and commercial manufacture for an immunomodulatory programme |
| mAbTree Biologics (Switzerland) | Global | Co-development of a novel immuno-oncology monoclonal antibody; US FDA Orphan Drug Designation received January 2026 |
| Gate2Brain S.L. (Spain) | Global | Blood-brain-barrier peptide shuttle platform; lead asset in paediatric brain cancer with FDA and EMA Orphan Drug Designations |
| Pharma Pharmaceutical Industries (PPI) | Saudi Arabia | Joint venture for supply and subsequent local manufacture in the Kingdom |
| IIT Dharwad | India | Joint research, internships and faculty-industry collaboration in biologics |
Shilpa Medicare Limited supplies Active Pharmaceutical Ingredients, finished dosage forms and biologics to customers in more than 50 countries. All manufacturing is located in India across 10+ regulator-approved sites in Karnataka, Telangana and Gujarat, supported by international offices in the United States, Austria, the United Kingdom, Spain and the United Arab Emirates operating under the Koanaa Healthcare brand.
API Units I and II (Raichur), the biologics campus (Dharwad), recombinant human albumin fermentation (Kadechur, Yadgir district), and the oral dissolving film and transdermal patch facility with co-located formulation R&D (Dabaspet, Bengaluru).
The oncology oral solids and sterile injectables facility (Jadcherla SEZ, Mahabubnagar) and the analytical and bioanalytical research centre (Nacharam, Hyderabad).
Contract research and formulation development at Sanand, Ahmedabad, through FTF Pharma.
Entity | Location | Role |
|---|---|---|
| Shilpa Pharma Inc. | Doylestown, Pennsylvania, USA | United States commercial and regulatory front-end |
| Koanaa Healthcare GmbH | Austria | European Union hub; marketing authorisations and distribution |
| Koanaa Healthcare Ltd | United Kingdom | UK market access and distribution |
| Koanaa Healthcare Spain S.L. | Spain | Iberian market access |
| Koanaa International FZ LLC | Dubai, UAE | Middle East and North Africa hub; joint venture partner in Saudi Arabia |
Regulated markets
United States · European Union · United Kingdom · Japan · South Korea · Canada · Australia · Russia and the Eurasian Economic Union
High-growth and emerging markets
Brazil · Mexico · Peru · Colombia and Latin America (through the SteinCares partnership across 30+ countries) · Saudi Arabia and the Gulf Cooperation Council · South Africa · MENA · Southeast Asia · India
Shilpa Medicare has held Star Export House status from the Government of India since 2008. API Unit II at Raichur operates as a 100% Export Oriented Unit, and the Jadcherla finished dosage facility is located within a pharmaceutical Special Economic Zone.
Shilpa Medicare operates five research and development centres across India with more than 400 R&D professionals, covering process chemistry, complex formulation development, nanotechnology, analytical and bioanalytical science, and biologics. The company has filed more than 585 patents, of which approximately 46 have been granted, and holds DSIR recognition from the Government of India for its research units.
Centre | Location | Research Focus |
|---|---|---|
| API Research | Raichur, Karnataka — co-located with API Unit II | Process chemistry, route scouting, asymmetric and chiral synthesis, polymorph and particle engineering, peptide synthesis, polymer chemistry, impurity science |
| Formulation Development Centre | Dabaspet, Bengaluru, Karnataka | Injectables, oral solids, transdermal, topical, ophthalmic and film dosage forms; complex generics and 505(b)(2); nanotechnology centre established 2015 |
| Analytical & Bioanalytical Centre | Nacharam, Hyderabad, Telangana | Analytical method development and validation, impurity characterisation, LC-MS/MS bioanalysis at 20,000 samples per month, GLP-compliant PK studies |
| Biologics Research | Dharwad–Hubli, Karnataka | Cell line development, metabolic pathway engineering, high-density fermentation, protein characterisation; cGMP pilot facility partially funded by the National Biopharma Mission |
| FTF Pharma | Sanand, Ahmedabad, Gujarat | Drug development, novel dosage forms, regulatory strategy, IP evaluation, bioequivalence studies |
Domain | Patents Filed (Cumulative) |
|---|---|
| Formulations | 319 |
| Active Pharmaceutical Ingredients | 213 |
| Films & Topicals | 39 |
| Biologicals | 14 |
| Total | 585 |
Approximately 46 patents granted. The recombinant human albumin production technology is patented in both the United States and Europe. Shilpa Medicare also maintains an active trademark portfolio.
Pharma business of today has evolved and represents a paradigm shift from the past decade consequent to stringent Intellectual property driven needs of contemporary market. Understanding the trends, we at Shilpa Medicare have always endeavored for innovative and affordable healthcare solutions that would bring succor to patients in one way or the other.
In this line of thought and perspective, we are continuously surmounting challenges and accepting new responsibilities so as to transform our vision into reality. As a growing organization, we are aware that we can't achieve our goals singly. It's an age of cooperation and assimilation. Hence, we collaborate and work in unison with a large number of reputed and like-minded partners and clients who can nourish our aspirations.
We commit to quality and superior standards in all areas of operation and are determined to create value for all our stakeholders and partners. We discern market opportunities and actualize them up with quick decision making, so as to enable timely introduction of affordable generics to reach needy patients as quickly as possible.
We have expertise and know-how for the development and production of simple to complex products, ranging across APIs, formulations and new drug delivery systems. To seize the lead and overwhelm competition is our belief that ensures success in all that we pursue. We are the best and aspire to be the leader who strives to consistently deliver economically viable results.
Our team of employees is our biggest asset and their motivation and commitment shall continuously impel us to invest in the future and lead us to our goals. We believe that every human being shall be cared for and we shall provide them hope during the difficult times of their lives, as medicine can cure physical diseases to some extent but not hopelessness.
With our sincere efforts we shall be among the leaders in healthcare industry, providing affordable medicines to all the strata of society.
