Explore our world-class manufacturing facilities across India, equipped with state-of-the-art technology and global regulatory approvals
Shilpa Medicare operates 6 state-of-the-art manufacturing facilities across India, each designed to meet the highest international quality standards and equipped with cutting-edge technology for pharmaceutical manufacturing.
Our facilities are strategically located and specialized to serve different segments of pharmaceutical manufacturing, from API production to finished dosage formulations. Each unit operates under strict cGMP guidelines and holds multiple international regulatory approvals including USFDA, EMA, and WHO-GMP.
Click on any facility to learn more about its capabilities and specializations
All our manufacturing facilities are approved by major regulatory authorities worldwide including USFDA, EMA, WHO-GMP, TGA, and multiple other international agencies. We maintain the highest standards of quality, safety, and compliance across all operations.
Unit | Location | Products | Key Capacity | Approvals |
|---|---|---|---|---|
| API Unit I | Deosugur Industrial Area, Shaktinagar, Raichur, Karnataka | Oncology and non-oncology APIs, HPAPI, NCEs, peptides, polymers | ~650 KL across 11 blocks (4 oncology, 7 non-oncology) | US FDA, EU-GMP, TGA, PMDA, MFDS, ANVISA, COFEPRIS, Health Canada, Russian GMP, WHO-GMP |
| API Unit II (100% EOU) | Raichur Industrial Growth Centre, Chicksugur, Raichur, Karnataka — 22.4 acres | Non-oncology and specialty APIs, custom synthesis, CRAMS | ~510 KL across 10 blocks (5 oncology, 5 non-oncology) | US FDA, EU-GMP, WHO-GMP, TGA, PMDA, MFDS, Health Canada, ANVISA, COFEPRIS, Russian GMP |
| Unit IV | Pharma Formulation SEZ, TSIIC Green Industrial Park, Polepally, Jadcherla, Mahabubnagar, Telangana — 14 acres | Oncology oral solids and sterile injectables; OEL-4 containment | ~25 mn tablets, ~4 mn capsules, ~3 mn liquid vials, ~2 mn lyophilised vials p.a. | EU-GMP, TGA, ANVISA, COFEPRIS, Health Canada, WHO-GMP, SAHPRA, SFDA, DIGEMID, EAEU, CDSCO |
| Unit V — Shilpa Biologicals | Belur Industrial Area, Dharwad, Karnataka — 11 acres | Biosimilars, mAbs, ADC drug substance, biologics CDMO | 4,000 L × 2 single-use mammalian; 1,000 L × 2 microbial; 3 fill-finish suites; 200 L bioconjugation | EU-GMP (zero observations), Oman MoH, DSIR |
| Unit VI | Avarehalli Industrial Area, Sompura, Dabaspet, Bengaluru, Karnataka | Oral dissolving films, transdermal patches; co-located formulation R&D | ~50 mn film units, ~30 mn patches p.a.; coating 120–540 mm | US FDA, EU-GMP, UK MHRA, TGA, SFDA, WHO-GMP |
| Unit VII | Plot 79, Road No. 15, IDA Mallapur, Nacharam, Hyderabad, Telangana | Analytical and bioanalytical research | ~40,000 sq ft; 20,000 LC-MS/MS samples per month | US FDA, EU-GMP, UK MHRA, ANVISA, CDSCO, NABL, GLP, DSIR |
| Shilpa Biocare | Kadechur–Badiyal Industrial Area, Yadgir district, Karnataka | Recombinant human albumin | 200+ KL fermentation; product vessels 5–50 KL | PMDA, Russian GMP, WHO-GMP, MFDS, Health Canada; audit-ready for US FDA and EMA |
| Shilpa Therapeutics site | IDA Phase III, Cherlapally, Hyderabad, Telangana | Oral fast-dissolving strips | 800,000 units per day across 8 packing tracks | CDSCO |
| FTF Pharma | Xcelon Industrial Park, Sanand, Ahmedabad, Gujarat | Contract research and formulation development | — | DSIR |
Project | Location | Status |
|---|---|---|
| New oncology API block | Raichur | Completion targeted end FY2027 |
| Dedicated peptide block | Raichur | Under construction — targeted to be among India's largest SPPS capacities |
| UDCA and tranexamic acid capacity | Raichur | Expansion underway |
| ADC drug substance GMP qualification | Dharwad | Facility commissioned June 2026; GMP qualification Q1 FY2027 |
| Third injectable combination line (liquid, lyophilised, dry powder) | Jadcherla | Commissioning |
| Saudi Arabia manufacturing | Kingdom of Saudi Arabia | Joint venture with PPI; Phase 2 involves technology transfer and local manufacture |
Complete range from small molecules to complex peptides and HPAPIs with advanced containment (OEL Band 1–5)
Dedicated polymer chemistry capabilities — PEG, PLGA, block copolymers — alongside full CDMO services from development to commercial supply
Phase-appropriate clinical supply manufacturing from Phase I IND batches through commercial validation — GMP-compliant at every stage
Solid oral, injectable, TDS, OTF, and complex dosage forms with novel drug delivery technologies
USFDA, EDQM, EU GMP, Health Canada, ANVISA, TGA, WHO GMP approved — multiple international regulatory certifications
Comprehensive analytical and bioanalytical testing, ISO 14001 / 45001 / 50001 certified environmental and safety management
Each facility is designed with a focus on operational excellence, safety, and environmental responsibility. We continuously invest in upgrading our infrastructure, adopting new technologies, and training our workforce to maintain our position as a leading pharmaceutical manufacturer.
