Shilpa Biologicals is a fully integrated biopharmaceutical company in India, focused exclusively on biologics. We develop and manufacture biologics for partners worldwide, bringing novel biologics, biosimilars, antibody drug conjugates and recombinant human albumin together under one organisation and one quality system.

A Dedicated, Fully Integrated Biologics Company in India

As a biologics company India can rely on, Shilpa Biologicals gives partners one accountable point of contact for a molecule, from its earliest research stage through to commercial supply. This integrated biologics company model removes the friction of coordinating separate vendors for development, manufacturing and testing, so a program moves with one team that understands the full journey of a biologic. Under one roof we bring together:

• Novel biologics development and manufacturing
• Biosimilars across multiple therapy areas
• Antibody drug conjugates and bioconjugation
• Recombinant human albumin on the Srbumin platform

That continuity is the foundation of how we work and the reason partners treat us as a long term extension of their own teams.

End-to-End Biologics Development and Manufacturing in India

Our working approach centres on genuine end-to-end biologics solutions delivered from one integrated campus in Dharwad. Keeping every stage of biologics manufacturing India under a single quality system shortens technical transfer, protects timelines and removes the risk that appears when a program is split across multiple sites. As a biologics solutions provider, we carry a molecule through the complete value chain:

• Mammalian cell culture and CHO cell line development
• Microbial fermentation for proteins and rHA support
• Drug product and aseptic fill-finish
• Analytical and stability testing

We scale each program in step with its needs, from early development batches through to larger commercial volumes, holding one consistent thread of quality, data and documentation from the first cell line to the final vial.

A WHO-GMP Biologics Manufacturer Trusted Across Regulated Markets

Trust in biopharmaceutical manufacturing is earned through quality systems rather than claims. Shilpa Biologicals operates as a WHO-GMP biologics manufacturer with controls benchmarked for the most tightly regulated markets:

• WHO-GMP certified biologics manufacturing
• ICH and PIC/S GMP aligned quality systems
• CDSCO compliant processes and documentation
• EU GMP approved fill-finish line

Every program is developed and released to meet the expectations of regulators across the United States, Europe, Canada, Brazil and Japan. This commitment to global quality standards, supported by the scientific depth of an experienced team, lets partners place complex biologics programs with us and stay confident in the outcome.

Biosimilars and an Affordable Biopharmaceuticals Manufacturer Widening Access

A core part of what Shilpa Biologicals provides is a growing biosimilars portfolio that widens patient access to high cost biologics. As a biosimilars and biologics company, we are developing candidates across oncology, autoimmune and dermatology indications, giving health systems and licensing partners more affordable routes to established therapies. Biosimilars will be available commercially after relevant patent expiry.

As an affordable biopharmaceuticals manufacturer, our purpose is to help high quality biopharmaceutical products reach more patients, and affordability here is the result of efficient processes and an optimised cost base, never a compromise on quality, safety or compliance.

Novel Biologics Development Partner: CDMO, ADCs and Recombinant Human Albumin

Beyond biosimilars, Shilpa Biologicals works as a novel biologics development partner across three further areas:

• Biologics CDMO services for mammalian and microbial molecules
• Antibody drug conjugate and bioconjugation capability for complex oncology programs
• Recombinant human albumin and albumin fusion technology on the proprietary Srbumin platform, animal free and available for licensing and supply

Bringing these very different molecule types under one quality system is what separates a fully integrated biologics company from a single service vendor, and it gives partners room to grow the relationship as their pipeline evolves.

Why Global Partners Choose an Indian Biopharma Manufacturer with Global Standards

For partners assessing options across the wider biopharmaceutical industry, an Indian biopharma manufacturer with global standards offers a combination that is hard to find:

• Fully integrated capabilities from cell line to fill-finish
• Global quality standards built for regulated markets
• Affordability without a quality compromise
• A deep scientific bench across biologic platforms
• A flexible, agile model that adapts to your stage and scale

The result is a global biologics company with roots in India and real reach across its priority markets. To start a conversation, share your molecule and our scientific team will respond.