Mission
To innovate and develop high-quality, affordable biopharmaceuticals for patients worldwide.
About Shilpa Biologicals
CDMO services, biosimilars, ADCs and bioconjugation, and recombinant human albumin — developed and manufactured end to end at our campus in Dharwad, India.
Pioneering Advanced Biologics. Expanding Global Healthcare Access.
Who we are
At Shilpa Biologicals, our mission is to accelerate the development and commercialization of complex biopharmaceuticals, making life-saving biologic therapies accessible and affordable for patients worldwide. By combining scientific innovation, state-of-the-art biomanufacturing infrastructure, and an unwavering commitment to quality, we bridge the gap between gene expression and commercial delivery.
Shilpa Biologicals - At a Glance
- 01 Company Shilpa Biologicals Pvt. Ltd.
- 02 Parent heritage Shilpa Medicare Limited NSE: SHILPAMED · established 1987
- 03 Headquarters & operations Dharwad, Karnataka, India
- 04 Global offices New Jersey, United States
- 05 Business verticals Biologics CDMO · Biosimilars · ADCs & Bioconjugation · Recombinant Human Albumin
- 06 Scale & impact Supporting 25+ programs for partners across 15+ countries
- 1987Parent established
- 2016Entry into biologics
- 2020Formally incorporated
Our Identity & Heritage: Built on Decades of Excellence
Shilpa Biologicals operates as the dedicated biologics subsidiary of Shilpa Medicare Limited (NSE: SHILPAMED), a publicly listed pharmaceutical pioneer established in 1987. Backed by nearly four decades of proven global expertise in oncology, specialty APIs and finished dosage formulations, our parent group provides the operational maturity, global supply chain strength and financial stability that form our foundation.
Following strategic entry into biologics in 2016 and formal incorporation in 2020, Shilpa Biologicals functions as an independent biopharmaceutical enterprise. Operating with its own purpose-built campus, dedicated leadership team and specialised quality system, we combine multi-decade pharmaceutical reliability with cutting-edge biomanufacturing agility, eliminating multi-vendor friction and accelerating timelines.
Our mission and vision
Vision
A world where every patient has access to the best biologic medicines.
Quality & compliance
Uncompromised quality and global regulatory standards
As an integrated biopharmaceutical developer and CDMO, we operate under a unified, digitalised quality system engineered to meet the standards of global regulatory agencies. Our Dharwad campus adheres to international cGMP guidelines, ensuring rapid, compliant global market access.
WHO-GMP
Quality assurance
Compliant with World Health Organization Good Manufacturing Practices for biopharmaceutical quality assurance.
ICH
Analytical & stability
Analytical characterisation and stability protocols benchmarked to ICH guidelines for US, EU and global markets.
PIC/S GMP
Process reproducibility
Operating to Pharmaceutical Inspection Co-operation Scheme guidelines for process reproducibility and safety.
CDSCO
Commercial licence, India
Licensed by the Central Drugs Standard Control Organization, Government of India, for commercial biomanufacturing and clinical supply.
EU GMP
Sterile fill-finish line
Certified by European competent authorities for sterile filling, lyophilizates, isolator lines and QC laboratories.
Data integrity & automation
eBMR, LIMS, cell banking
Automated eBMR, an integrated LIMS and validated GMP cell banking suites make every batch audit-ready as it is written.
Advanced Facilities & Technical Capabilities
State-of-the-Art Biomanufacturing Hub | Dharwad, India
Spread across an expansive 11-acre industrial campus in Belur, Dharwad (Karnataka), our R&D and commercial manufacturing facilities integrate cutting-edge technology to reduce time-to-market and de-risk process scale-up.
Dharwad, Karnataka, IndiaUpstream mammalian & microbial suites
Flexible, multi-product upstream trains using single-use bioreactors and stainless-steel fermenters. Capabilities include high-density fed-batch and continuous perfusion modes, scaling to multi-thousand-litre commercial capacities.
Integrated ADC manufacturing facility
A specialised, high-containment cGMP unit for antibody-drug conjugates, covering payload synthesis, linker development, mAb production, conjugation and purification under one roof.
Dedicated MSAT facility
A 3,500 sq. ft. Manufacturing Science and Technology unit optimised for seamless technology transfer, process scale-down and troubleshooting.
Aseptic fill-finish & packaging
Multi-format filling lines inside isolators supporting ready-to-use vials, pre-filled syringes and cartridges, with integrated lyophilisation and automated packaging.
Areas we serve
Global Reach, Rooted in India
Shilpa Biologicals serves biopharma partners from a manufacturing campus in Dharwad, India, with a commercial presence in New Jersey, United States. This dual presence ensures that programs are supported in the same time zones as the teams running them.
United States
Canada
Austria
Belgium
France
Germany
Italy
Netherlands
Poland
Portugal
Spain
Sweden
Switzerland
United Kingdom
Australia
Japan
South Korea
Brazil
Russia
IndiaCampus
Indonesia
Malaysia
Philippines
Thailand
Egypt
Israel
Kenya
Nigeria
Saudi Arabia
South Africa
Türkiye
United Arab Emirates
Argentina
Chile
Colombia
Mexico
Leadership
Driven by renowned industry pioneers and scientific visionaries
Shilpa Biologicals is driven by an experienced coalition of industry veterans, research scientists and regulatory experts guiding our strategic growth.
Dr. Uday Harle
Chief Executive Officer (CEO) of SHILPA BIOLOGICS PVT LTD.
Nearly 25 years in global pharmaceutical strategy, with leadership positions spanning biologics development and commercialisation.
Ms. Shriya Khandwe
Vice President- Business & Commercial Head (Global) at Shilpa Biologicals
Oversees the Europe and Canada formulations business and the global biologicals portfolio. M.S. Pharmacology (NIPER), MBA (IIM Kozhikode); previously Dr. Reddy’s, Sun Pharma and IMS Health.
Dr. Puspadhwaja Mall
Head, R&D, Operations and Portfolio management
19+ years specialising in monoclonal antibodies, recombinant proteins and nanobodies.
Mr. Balaji Sunkara
Associate Vice President
Head - Regulatory Affairs
21+ years securing complex biotech approvals across the US, EU, UK and 90+ emerging markets.
Mr. PV Narasimha Rao
CHRO (Chief Human Resource Officer)
An alumnus of the Indian Institutes, with a career shaping high-performance organisational cultures.
Our Sustainability & ESG Commitments
Responsible & Eco-Conscious Biomanufacturing
As part of our commitment to sustainable industrial practices and environmental stewardship, our biomanufacturing complex operates as a certified Zero Liquid Discharge (ZLD) facility.
We actively reduce our carbon footprint through water recycling, single-use waste management protocols, energy-efficient HVAC technology, and strict adherence to global Environmental, Health, and Safety (EHS) standards.
- Water recycling
- Single-use waste protocols
- Energy-efficient HVAC
- Global EHS standards
Accelerate your biologic pipeline with Shilpa Biologicals
Whether you require rapid clone development, hybrid scale-up capacity, or commercial biomanufacturing, we are equipped to take your molecule from gene to market.
Inside the campus
Where the work actually happens
Good to know
What you need to know about Shilpa Biologicals
The questions partners, regulators and prospective collaborators ask most often. If yours is not here, our team will answer it directly.
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.
We operate from an integrated biologics campus in Dharwad, Karnataka, India, with a commercial office in New Jersey, United States, 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.
We serve biopharma innovators across the United States, European Union, Canada, Brazil and Japan, with secondary markets spanning the Middle East, Southeast Asia and Latin America.
We are the dedicated biologics subsidiary of Shilpa Medicare Limited. While our parent company focuses on APIs and specialty pharmaceuticals, we operate independently with our own biologics campus, team and specialised quality systems.
Yes, we actively seek licensing and distribution partners worldwide. Please note that all biosimilars will only be made commercially available after their respective patents have expired.
We focus exclusively on biologics, including monoclonal antibodies, recombinant proteins, ADCs and recombinant human albumin. We do not manufacture small molecules or traditional generics.
Our pipeline spans oncology, autoimmune and dermatology indications, including biosimilar candidates referencing adalimumab, pembrolizumab, nivolumab, daratumumab, trastuzumab emtansine and dupilumab. Biosimilars will be available commercially after relevant patent expiry.
Srbumin is our proprietary recombinant human albumin and albumin-fusion platform. It is an animal-free albumin source and a novel biologics platform available for licensing and supply.
Partners choose us for a fully integrated model (cell line to fill-finish under one roof), global quality standards (WHO-GMP, ICH, EU GMP fill-finish), Indian cost-efficiency, deep scientific expertise and a flexible hybrid CDMO model that adapts to each program’s stage and scale.