An end-to-end biopharmaceutical company delivering global-quality biologics, affordably, from India to the world. Novel biologics, biosimilars, ADCs and recombinant human albumin, all under one integrated quality system.
25+ programs supported WHO-GMP & EU-GMP approved Serving the US, EU, Canada, Brazil & Japan
Faster timelines, higher titres, lower cost of goods, one integrated campus
One accountable partner across novel biologics, biosimilars, ADCs and recombinant human albumin.
Shilpa Biologicals is a WHO-GMP biologics manufacturer operating to ICH, PIC/S GMP and CDSCO-aligned quality systems, with an EU GMP-approved fill-finish line. Every program is developed and released under internationally benchmarked controls, so your molecule is built to the expectations of regulators across the US, EU, Canada, Brazil and Japan.
Compliant with World Health Organization Good Manufacturing Practices for global quality assurance.
Guided by International Council for Harmonisation standards for safe and effective medicines.
Adhering to PIC/S Good Manufacturing Practices for pharmaceutical quality and consistency.
Approved by CDSCO, Government of India, ensuring regulatory compliance and product safety.
EU GMP certified fill-finish facility meeting the highest European quality standards.
From global pharmaceutical groups to clinical-stage biotechnology innovators, partners across 30+ countries rely on Shilpa Biologicals for biologics, biosimilars, ADC programs and recombinant human albumin.
01/04
End-to-end contract development and manufacturing for mammalian and microbial biologics, from cell line to commercial fill-finish, including integrated antibody-drug conjugate (ADC) drug-substance manufacturing.
One accountable partner across the entire biologics lifecycle, engineered for quality, speed and global reach.
Request a QuoteOne partner from cell line to fill-finish. No hand-offs, no lost time between development and supply.
WHO-GMP, ICH, PIC/S and an EU-GMP fill-finish line, trusted across the world’s most regulated markets.
Global-quality biologics engineered for cost-efficiency, broadening access from India to the world without compromising on standards.
Seasoned scientific talent across mammalian, microbial, ADC and albumin-fusion platforms, supporting complex programs from discovery to commercial supply.
Adaptive capacity and fast, responsive timelines that move a molecule from DNA to IND on aggressive commercial schedules.
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.
Commercial offices in the United States, Spain, Russia and Japan, backed by a head office, seven manufacturing sites and five R&D centres in India, so a programme is supported in its own time zone.
United States
Business development and partner support across North America.
Spain
European commercial and regulatory point of contact.
Russia
Commercial office serving Russia and the surrounding markets.
Japan
Commercial office supporting partners across the Japanese market.
Karnataka, India
The group's head quarters, alongside its largest manufacturing and R&D base.
Maharashtra, India
Corporate and commercial office for the Indian market.
India
India
Stay updated with our latest announcements, partnerships, achievements and insights shaping the future of biologics.
Book time with our scientific and business development teams at the tradeshows and conferences we attend through the year.
Three days on stand with our CDMO, ADC and recombinant albumin teams.
All event details are subject to change. Please check back for the latest schedule.
Everything you need to know about working with Shilpa Biologicals. Can't find your answer?
Talk to our teamShilpa 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.
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.
Shilpa Biologicals operates from an integrated biologics campus in Dharwad, Karnataka, India, serving partners across the US, EU, Canada, Brazil and Japan.
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.
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.
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.
Shilpa Biologicals is the dedicated biologics enterprise of Shilpa Medicare, focused exclusively on biologics, biosimilars, ADCs and recombinant human albumin.
Partners choose Shilpa Biologicals for a fully integrated model, global quality standards and Indian cost-efficiency. One accountable partner from cell line to fill-finish.
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.
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:
That continuity is the foundation of how we work and the reason partners treat us as a long term extension of their own teams.
Our working approach centres on genuine end-to-end biologics solutions delivered from one integrated campus in Dharwad. Keeping every stage of biologics manufacturing in 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:
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.
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:
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.
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.
Beyond biosimilars, Shilpa Biologicals works as a novel biologics development partner across three further areas:
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.
For partners assessing options across the wider biopharmaceutical industry, an Indian biopharma manufacturer with global standards offers a combination that is hard to find:
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.
Serving partners across the Americas, Europe and the Asia-Pacific, with dossiers and batch release supported market by market.
Share your program and our scientific team will respond at the earliest, whether you need a CDMO partner, biosimilar licensing or recombinant albumin supply.
