Shilpa CDMO operates from a 34-acre, 100% export-oriented campus in Raichur, Karnataka, India, where its corporate office is also located. It is a wholly owned subsidiary of Shilpa Medicare Limited, which is listed on the National Stock Exchange of India (NSE: SHILPAMED), and draws on more than three decades of pharmaceutical experience within the group. The website describes the CDMO as supporting more than 10 active new chemical entity (NCE) programmes, from route scouting and process development through to scale-up and commercial supply.

The site reports regulatory approvals from 10 agencies, including the US FDA, EMA, PMDA (Japan), KFDA (South Korea), TGA (Australia), ANVISA (Brazil), and COFEPRIS (Mexico), alongside EU GMP certification. Its main API manufacturing unit (Unit I) has six manufacturing blocks, three for oncology and three for non-oncology, with reactor capacity of about 38,000 L for non-oncology and about 28,000 L for oncology. A second 100% export-oriented unit houses API manufacturing and R&D. The campus offers OEB-5 containment for potent compounds under a unified quality system.

Shilpa CDMO states that it serves partners in more than 50 countries, including the United States, Germany, France, Japan, China, Brazil, Australia, and the Middle East. It publishes client testimonials from a Spanish mid-sized pharma, a US oncology-focused NASDAQ-listed biotech, a US big pharma, a German virtual biotech, and others, all unnamed. Its published case studies cover sterol API route scouting and supply, flow chemistry reactor customisation, and clinical API process development. It also lists sustainability and ESG credentials, including ISO 14001, and corporate social responsibility initiatives. The site states that it partners only with pharmaceutical manufacturers, biotech companies, and international trading firms, and that minimum order quantities apply.

Key Products and Services

CDMO Services

• Route scouting, process research and development, and scale-up from pilot to commercial campaigns
• Technology transfer, risk assessment, and regulatory support
• Preclinical, clinical, and commercial supply, including toxicology batches and NCE development solutions

Drug Substances and Products

• APIs, covering both oncology and non-oncology compounds, with additional generic APIs offered under the Shilpa brand
• API intermediates
• HPAPIs — high-potency APIs manufactured with containment up to OEB-5
• Peptides — therapeutic peptide synthesis for research, clinical development, and commercial use
• Polymers — pharmaceutical polymers for stability, solubility, and controlled drug delivery
• Specialty chemicals for pharmaceutical, biotech, and industrial applications

ADC and Conjugation Chemistry

• ADC linkers and payloads for antibody-drug conjugates and peptide-drug conjugates
• PEGs — PEG derivatives supporting bioconjugation and solubility

Analytical Services

• Structure elucidation, impurity evaluation and profiling, and standards qualification
• Analytical testing, method development and validation, and method transfer
• Polymorph profiling, photostability and forced degradation studies, and stability studies

Specialist Technologies

• Continuous flow chemistry, including reactor customisation and process development using flow technology

Shilpa CDMO is a mid-sized Indian CDMO focused on technically demanding small-molecule chemistry, with an emphasis on oncology, potent compounds, and ADC components. Its position rests on three strengths: regulatory approvals from several stringent authorities, large reactor capacity with containment for potent molecules, and parent group backing from a listed pharmaceutical company. Offering peptides, PEGs, linkers, payloads, and polymers alongside APIs gives it a broad palette for sponsors building complex modalities such as ADCs and conjugates, and suits customers who want to consolidate chemistry suppliers. Its cost position as an India-based export-oriented site is a typical commercial advantage against Western CDMOs. The reported figures (customers, projects, team size) did not load on the page reviewed, and several metrics are self-reported, so scale is best verified directly.