A Fully Integrated Biologics Company, From Cell Line to Fill‑Finish

Shilpa Biologicals is an end-to-end biopharmaceutical company delivering global-quality biologics, affordably — from India to the World.

Quality & Compliance

Built to the World's Highest Standards

Independently certified and internationally recognised — our quality systems, regulatory approvals and export credentials are benchmarked for the world's most demanding markets, so every program is built and released to global expectations.

Shilpa Biologicals laboratory and manufacturing
Single-site facility Cell line → Fill-finish
Who We Are

A Biologics Partner Built for the World

Shilpa Biologicals develops and manufactures complex biologics end-to-end — taking each program from cell line development through drug substance and final fill-finish, all within a single integrated site. Fewer hand-offs mean tighter control, faster timelines, and quality that holds from first vial to last.

By pairing scientific depth with internationally benchmarked quality systems, we make global-standard biologics genuinely accessible — helping partners bring affordable therapies from India to patients around the world.

  • Fully integrated, single-site value chain
  • WHO-GMP & EU-GMP aligned quality
  • Affordable, global-quality biologics
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Let’s build together

Partner with a fully integrated biologics company

Share your program and our scientific team will respond at its soonest — whether you need a CDMO partner, biosimilar licensing or recombinant albumin supply.

  • A response within two business days
  • Covered by mutual NDA on request
  • A direct line to our scientific team

Trusted by partners across the US · EU · Canada · Brazil · Japan

Our biologics solutions

Four integrated verticals

From molecule to vial — under one roof

Integrated end-to-end CDMO value chain

  1. Stage 01

    Mammalian Cell Culture

  2. Stage 02

    Microbial Fermentation

  3. Stage 03

    Drug Product / Fill-Finish

  4. Stage 04

    Analytical & Stability Testing

Why partners choose us

An Integrated Biologics Company, Built in India for the World

Shilpa Biologicals is an integrated biopharmaceutical company in India that develops and manufactures biologics for partners across the United States, Europe, Canada, Brazil and Japan. From a single integrated campus in Dharwad, we combine novel biologics development, biosimilars, antibody-drug conjugates and recombinant human albumin — the full breadth of modern biologics development and manufacturing in India, under internationally benchmarked quality.

As a novel biologics development partner, we bring together scientific depth, end-to-end biopharmaceutical manufacturing and a cost base that makes high-quality biologics more affordable. Whether you are advancing a first molecule or scaling toward commercial supply, Shilpa Biologicals offers a single, accountable home for your program — from cell line through final fill-finish.

  • Fully Integrated
  • Global Quality Standards
  • Affordability
  • High Skill Set
  • Flexibility & Agility
Shilpa Biologicals integrated campus
1 campus Dharwad, India → the World
Shilpa Biologicals

From novel biologics and biosimilars to recombinant human albumin, Shilpa Biologicals exists to make high-quality biopharmaceutical products more affordable and more accessible. As an affordable biopharmaceuticals manufacturer and a biosimilars and biologics company, we partner with innovators worldwide to bring the therapies patients depend on within reach — without compromising on the standards the biopharmaceutical industry demands.

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Global reach

Serving Biopharma Partners Across the Globe

One accountable partner in Dharwad, India — delivering global-quality biologics to regulated and emerging markets worldwide.

World map showing markets served by Shilpa Biologicals United States Canada United Kingdom European Union Brazil Japan IndiaDharwad, India
FAQ

Frequently Asked Questions

What does Shilpa Biologicals do?
Shilpa Biologicals is a fully integrated biologics company providing end-to-end biologics development and manufacturing across four verticals: biologics CDMO services, biosimilars, antibody-drug conjugates and recombinant human albumin, for biopharma partners worldwide.
Is Shilpa Biologicals a CDMO?
Yes. Shilpa Biologicals offers contract development and manufacturing (CDMO) for mammalian and microbial biologics, spanning cell culture, fermentation, drug product, aseptic fill-finish and analytical and stability testing — all on one integrated campus.
Where is Shilpa Biologicals located?
Shilpa Biologicals operates from an integrated biologics campus in Dharwad, Karnataka, India, serving partners across the US, EU, Canada, Brazil and Japan.
What certifications does Shilpa Biologicals hold?
Shilpa Biologicals is a WHO-GMP biologics manufacturer with ICH, PIC/S GMP and CDSCO-aligned quality systems and an EU GMP-approved fill-finish line.
What biosimilars is Shilpa Biologicals developing?
Its pipeline spans oncology, autoimmune and dermatology, including biosimilar candidates to adalimumab, pembrolizumab, nivolumab, daratumumab, trastuzumab emtansine and dupilumab. Biosimilars will be available commercially after relevant patent expiry.
What is Srbumin?
Srbumin is Shilpa Biologicals' proprietary recombinant human albumin and albumin-fusion platform — an animal-free albumin source and a novel biologics platform available for licensing and supply.
Is Shilpa Biologicals part of Shilpa Medicare?
Yes. Shilpa Biologicals is the dedicated biologics enterprise of Shilpa Medicare, focused exclusively on biologics, biosimilars, ADCs and recombinant human albumin.
Why choose Shilpa Biologicals as a biologics partner?
Partners choose Shilpa Biologicals for a fully integrated model, global quality standards and Indian cost-efficiency — a single accountable partner from cell line to fill-finish.
Countries we serve

Partnering with innovators worldwide

India Home base
  • India
North America 2 countries
  • United States
  • Canada
Europe 12 countries
  • United Kingdom
  • France
  • Germany
  • Spain
  • Italy
  • Netherlands
  • Sweden
  • Belgium
  • Switzerland
  • Poland
  • Portugal
  • Austria
Latin America 1 country
  • Brazil
Asia-Pacific 1 country
  • Japan
Know More about Shilpa Biologicals

About Shilpa Biologicals: A Fully Integrated Biopharmaceutical Company in India

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.