Sterile injectables, oral solids, oral dissolving films, transdermal systems, oral suspensions, topicals & ophthalmics, and novel drug delivery systems — developed and manufactured across our Jadcherla and Dabaspet facilities.
API characterization, excipient compatibility and risk assessment.
Prototype formulation, optimization and robustness studies.
Pilot and validation batches with process optimization.
cGMP commercial manufacturing with in-house quality control and QA.
Liquid injections, lyophilised vials, sterile powders and ready-to-use presentations at Jadcherla — ~3 million liquid vials and ~2 million lyophilised vials annual capacity, OEL-4 containment for oncology.
Tablets, capsules, modified-release and dispersible tablets at Jadcherla — ~25 million tablets and 4 million hard capsules annual capacity, including OEL-4 high-potency oncology oral solids.
Solvent-cast oral thin films at Dabaspet — ~50 million film units annual capacity. EMA marketing authorisation for rivaroxaban orodispersible films received September 2025.
Drug-in-adhesive matrix and multi-layer patches at Dabaspet — ~30 million patches annual capacity. EMA-approved rotigotine patch (December 2025); first US ANDA filed February 2026.
Dossier-ready oncology oral suspensions — imatinib, capecitabine, temozolomide, sunitinib, methotrexate and lenalidomide — for paediatric, geriatric and dysphagic patients.
Creams, sprays, solutions and lotions, including the world's first tranexamic acid 10% haemostatic spray, plus sterile ophthalmic solutions and suspensions.
Liposomes, nanoparticles, nanoemulsions and peptide formulations from our nanotechnology research centre established at Bengaluru in 2015, including our nab-paclitaxel programme.
Capability | Specification |
|---|---|
| Presentations | Liquid injections, lyophilised vials, sterile powders, ready-to-use (RTU) injectables |
| Lines | Two commercial liquid/lyophilisation lines; a third combination line (liquid, lyophilised and dry powder) commissioning |
| Containment | OEL-4, suitable for cytotoxic and high-potency compounds |
| Annual capacity | ~3 million liquid vials; ~2 million lyophilised vials |
| Site | Unit IV, Pharma SEZ, Polepally, Jadcherla, Mahabubnagar, Telangana |
| Approvals | EU-GMP, TGA Australia, ANVISA Brazil, COFEPRIS Mexico, Health Canada, WHO-GMP, SAHPRA, SFDA Saudi Arabia, DIGEMID Peru, EAEU, CDSCO |
Product | Presentation |
|---|---|
| Azacitidine for injection | 25 mg/mL — 100 mg vial |
| Bendamustine hydrochloride for injection | 25 mg/mL — 100 mg vial |
| Bortezomib ready-to-use | 3.5 mg / 1.4 mL |
| Busulfan injection | 6 mg/mL |
| Clofarabine injection | 1 mg/mL — 20 mg vial |
| Cyclophosphamide powder for injection | 500 mg, 1 g, 2 g |
| Docetaxel injection | 20 mg/mL — 20 mg, 80 mg, 160 mg vials |
| Gemcitabine injection ready-to-use | 38 mg/mL |
| Irinotecan hydrochloride injection | 20 mg/mL — 20 mg, 40 mg, 100 mg, 300 mg vials |
| Melphalan for injection | 50 mg vial |
| Pemetrexed for injection | 100 mg and 500 mg vials |
| Pemetrexed ready-to-use | 10 mg/mL |
Shilpa Medicare's injectable pipeline includes 505(b)(2) and differentiated products rather than only generic equivalents — including an extended-release ondansetron injection (Oeris™) with positive Phase 3 results, and nab-paclitaxel, with European filings in progress.
Capability | Specification |
|---|---|
| Technology | Solvent casting with water-based soluble polymer matrix |
| Coating width | 120 mm to 540 mm |
| Annual capacity | ~50 million film units |
| Taste masking | In-house taste-masking and flavour development |
| Site | Unit VI, Avarehalli Industrial Area, Sompura, Dabaspet, Bengaluru, Karnataka |
| Co-located R&D | Formulation Development Centre on the same site |
| Approvals | US FDA, EU-GMP, UK MHRA, SFDA Saudi Arabia, WHO-GMP |
Product | Strengths |
|---|---|
| Betahistine dihydrochloride | 8 mg, 16 mg, 24 mg |
| Bilastine | 10 mg, 20 mg |
| Melatonin | 3 mg |
| Methylcobalamin | 500 mcg, 1000 mcg, 1500 mcg |
| Ondansetron hydrochloride | 2 mg, 4 mg, 8 mg |
| Paracetamol | 60 mg, 80 mg, 120 mg |
| Pregabalin | 25 mg, 50 mg, 75 mg |
| Rivaroxaban | 2.5 mg, 10 mg, 15 mg, 20 mg |
| Sildenafil citrate | 25 mg, 50 mg |
| Simethicone | 62.5 mg |
| Tadalafil | 5 mg, 10 mg, 20 mg |
| Vitamin D3 | 400 IU to 60,000 IU |
In September 2025 Shilpa Medicare received European Medicines Agency approval for rivaroxaban orodispersible films — demonstrating that the ODF platform can carry a complex, narrow-therapeutic-index anticoagulant through the most demanding regulatory pathway, not only vitamins and consumer products.
Product | Strengths |
|---|---|
| Axitinib tablets | 1 mg, 3 mg, 5 mg, 7 mg |
| Capecitabine tablets | 150 mg, 500 mg |
| Cyclophosphamide capsules | 25 mg, 50 mg |
| Erlotinib tablets | 25 mg, 100 mg, 150 mg |
| Ibrutinib capsules | 140 mg |
| Imatinib mesylate tablets | 100 mg, 400 mg |
| Lenvatinib capsules | 4 mg, 10 mg |
| Nilotinib capsules | 50 mg, 150 mg, 200 mg |
| Sunitinib malate capsules | 12.5 mg, 25 mg, 37.5 mg, 50 mg |
| Thalidomide capsules | 50 mg |
Capability | Specification |
|---|---|
| Patch types | Drug-in-adhesive matrix systems; multi-layer polymeric adhesive constructions; specialty patches |
| Wear duration | 24-hour, multi-day and weekly systems |
| Coating width | 120 mm to 540 mm |
| Annual capacity | ~30 million patches |
| Technical disciplines | Polymer and adhesive science, pressure-sensitive adhesive selection, permeation enhancer screening, backing and release-liner selection, die-cutting and pouching |
| Testing | In vitro skin permeation (Franz cell), adhesion and peel testing, cold-flow assessment, residual drug content, wear studies |
| Site | Unit VI, Dabaspet, Bengaluru, Karnataka — with co-located formulation R&D |
| Approvals | US FDA, EU-GMP, UK MHRA, TGA Australia, SFDA Saudi Arabia, WHO-GMP |
Product | Strengths | Indication |
|---|---|---|
| Rotigotine | 1, 2, 3, 4, 6, 8 mg / 24 hours | Parkinson's disease; restless legs syndrome |
| Diclofenac diethylamine | 100 mg, 200 mg | Localised pain and inflammation |
Product | Strengths | Indication |
|---|---|---|
| Donepezil — weekly patch | 5 mg, 10 mg / 24 hours | Alzheimer's disease |
| Rivastigmine | 4.6 mg, 9.5 mg, 13.3 mg / 24 hours | Alzheimer's and Parkinson's dementia |
| Nicotine | 7 mg, 14 mg, 21 mg / 24 hours | Smoking cessation |
| Scopolamine | 1 mg / 72 hours | Motion sickness; post-operative nausea |
| Ketoprofen patch | — | Localised pain and inflammation |
The rotigotine transdermal patch received EMA final approval in December 2025, with European launch planned for the first half of FY2027. In February 2026 Shilpa Medicare filed its first United States ANDA for a transdermal product — also rotigotine — marking entry into the US transdermal market. Very few Indian manufacturers hold both an EU approval and a US filing for a transdermal system.
Product | Strength | Status |
|---|---|---|
| Imatinib | 80 mg/mL | Dossier available |
| Capecitabine | 200 mg/mL | Dossier available |
| Temozolomide | 30 mg/mL | Dossier available |
| Sunitinib | 50 mg / 5 mL | Dossier available |
| Methotrexate | 2.5 mg/mL | Dossier available |
| Lenalidomide | 25 mg / 5 mL | Dossier available |
| Dasatinib | 40 mg/mL | In development |
| Erlotinib | 20 mg/mL | In development |
Shilpa Medicare's tranexamic acid spray 10% is the world's first tranexamic acid haemostatic spray. Delivering this established antifibrinolytic agent as a metered topical spray addresses surface bleeding directly — in dermatological procedures, wound care and surgical settings — without systemic exposure.
Product | Strength | Status |
|---|---|---|
| Tranexamic acid spray | 10% | World's first haemostatic spray — dossier available |
| Acyclovir cream | 5% | Dossier available |
| Dutasteride topical solution | 0.05% | In development |
| Topical alopecia lotion | — | Pivotal clinical trial initiated January 2026 |
Liposomal encapsulation improves therapeutic index by altering biodistribution — concentrating drug at target tissue while reducing exposure elsewhere. Covers formulation development, lipid selection and characterisation, encapsulation efficiency optimisation, size distribution and lamellarity control, sterile processing, stability evaluation and scalable manufacture, focused on oncology and specialty therapeutics.
Enhances solubility, bioavailability and targeted delivery for molecules that resist conventional formulation. Capabilities include particle engineering and size control, surface modification, protein-bound and polymeric nanoparticle systems, physicochemical characterisation, and scalable manufacture. Our nab-paclitaxel programme — an albumin-bound paclitaxel nanoparticle — has European filings in progress.
Delivers improved solubilisation, absorption and bioavailability for poorly water-soluble drugs, across oral, injectable, topical and specialty applications. Capabilities include emulsification process development and optimisation, droplet size distribution control, thermodynamic and kinetic stability assessment, surfactant/co-surfactant screening, and scale-up.
Formulation development for injectable peptide products and sustained-release peptide delivery systems, including analytical method development, stability evaluation, aggregation control, technology transfer and commercial manufacturing support.
