Shilpa Biologicals

What Shilpa Biologicals does

Shilpa Biologicals Private Ltd is a biopharmaceutical contract development and manufacturing organization (CDMO) and wholly-owned subsidiary of Shilpa Medicare Ltd (NSE: SHILPAMED), operating from a GMP manufacturing facility in Dharwad, Karnataka, India. The company provides end-to-end biologics services spanning biosimilar development and manufacturing, with a strategic focus on Antibody-Drug Conjugate (ADC) manufacturing, bioconjugation, and monoclonal antibody production for global pharmaceutical and biotech clients.

Its core technology platform centers on a fully integrated ADC manufacturing capability, one of the few in India, encompassing payload synthesis, linker development, monoclonal antibody production, and ADC conjugation under a single roof. The Dharwad facility includes a multi-client bioconjugation suite with 200L single-use reactors and lyophilization capacity up to 65 kg, designed to meet US FDA and European Medicines Agency standards. GMP qualification protocols were underway as of June 2026 to establish commercial readiness for global oncology clients.

The business model combines transaction-based contract manufacturing fees, long-term biosimilar licensing royalties (exemplified by the SteinCares partnership covering ~30 Latin American countries), and professional services for biologics development. Customer engagement is enterprise-direct B2B with quote-based pricing, supplemented by regional commercialization partners for geographic expansion. The company also co-develops proprietary rare disease biologics, notably MT0002 with mAbTree Biologics, which received US FDA Orphan Drug Designation in March 2026 for Essential Thrombocythemia and Polycythemia Vera.

Name

Shilpa Biologicals

Legal name

Shilpa Biologicals Private Ltd

Website

https://shilpabio.com

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

251–500 employees

Short description

Shilpa Biologicals is an India-based CDMO subsidiary of Shilpa Medicare offering end-to-end biosimilar development and integrated ADC manufacturing services to global pharmaceutical companies from its GMP facility in Dharwad, Karnataka.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Contract Development and Manufacturing (CDMO) Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Process Development & Tech Transfer Services (upstream/downstream) (HLAAAKAF)

Keywords

• Contract development manufacturing
• Biologics manufacturing
• Antibody drug conjugates
• Biosimilar development
• Bioconjugation services

Headquarters

HQ city

Dharwad

HQ country

India

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Supply Chain

Revenue model

1. Contract Manufacturing Services: CDMO services providing end-to-end manufacturing of ADC drug substances and biosimilars for pharmaceutical clients under GMP conditions meeting US FDA and EMA standards
2. Licensing Royalties: Revenue generated through licensing agreements where partners commercialize Shilpa Biologicals' developed biosimilars in specific geographic regions, with Shilpa retaining manufacturing responsibilities
3. Product Development Services: Contract development services for biologic and biosimilar development including product development and manufacturing from Dharwad, India facility

Go-to-market motion2 records

Distribution channels2 records

Marketing channels3 records

Core offering

Shilpa Biologicals is a Contract Development and Manufacturing Organization (CDMO) providing end-to-end, GMP-compliant manufacturing services for antibody-drug conjugates (ADCs) and biosimilars. Its service portfolio spans payload synthesis, linker development, monoclonal antibody production, and ADC conjugation, supported by a 200L single-use multi-client bioconjugation suite with lyophilization capacity up to 65 kg, all at its Dharwad, India facility.

Product overview

Shilpa Biologicals is a full-service contract development and manufacturing organization (CDMO) and subsidiary of Shilpa Medicare. The company operates a fully integrated biopharmaceutical manufacturing platform centered on its Dharwad, India facility. Core offerings include ADC GMP manufacturing services (encompassing payload synthesis, linker development, monoclonal antibody production, and ADC conjugation), a dedicated bioconjugation suite with 200L single-use reactors and lyophilization capacity, and biosimilar development and manufacturing. The company also collaborates with mAbTree Biologics on rare disease biologics. Shilpa Biologicals serves global pharmaceutical partners through strategic licensing agreements such as the SteinCares partnership for Latin American commercialization.

Differentiator

Problem solved

Functional benefit

Products and services

• ADC GMP Manufacturing Services Fully integrated, end-to-end Antibody-Drug Conjugate (ADC) manufacturing services spanning payload synthesis, linker development, monoclonal antibody production, and ADC conjugation, delivered under GMP conditions designed to meet US FDA and European Medicines Agency standards for global pharmaceutical and biotech clients.
• Dedicated Bioconjugation Suite Dedicated bioconjugation facility at the Dharwad, India site, with 200L single-use bioconjugation reactors and lyophilization capacity of up to 65 kg, supporting multi-client ADC and advanced bioconjugate manufacturing programs.
• Biosimilar Development and Manufacturing Services End-to-end biologics development and long-term commercial manufacturing services for biosimilars, delivered from the Dharwad, India facility, for pharmaceutical partners seeking manufacturing-ready biosimilar products for global commercialization.

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• mAbTree BiologicscoreStrategic or Co-development Partner · 12 March 2026Joint partnership for development of investigational monoclonal antibody targeting Essential Thrombocythemia and Polycythemia Vera, rare chronic blood cancers. Shilpa Biologicals and mAbTree Biologics received Orphan Drug Designation from U.S. FDA for this biologic candidate. The partnership enables advancement through IND-enabling studies with the objective of initiating first-in-human clinical trials. ODD provides regulatory and commercial incentives including development support, tax credits, and up to seven years of market exclusivity upon approval.
• SteinCarescoreOEM/ Whitelabel/ Licensing Partner · 25 February 2026Strategic licensing agreement for biosimilar commercialization across Latin America. Shilpa Biologicals handles product development and manufacturing from its Dharwad, India facility while SteinCares holds exclusive rights to register, commercialize, and distribute the biosimilar. The partnership marks Shilpa Biologicals' entry into the Latin American market, combining Shilpa's biologics manufacturing capabilities with SteinCares' integrated regional platform spanning 30 countries.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Lonza Group: Lonza is one of the world's largest biologics CDMOs and a leading provider of integrated ADC manufacturing, including payload, linker, and conjugation services. Directly comparable to Shilpa Biologicals as a global bioconjugate and biosimilar CDMO competitor targeting pharma customers.
• WuXi Biologics: WuXi Biologics is a major Asia-based biologics CDMO offering end-to-end monoclonal antibody, biosimilar, and increasingly ADC-related manufacturing services. Directly comparable in service portfolio, Asian cost-base positioning, and global pharma client base.
• Samsung Biologics: Samsung Biologics is a large-scale biologics CDMO with rapidly expanding ADC and bioconjugation capabilities. Competes directly for outsourced monoclonal antibody, biosimilar, and ADC manufacturing contracts from global pharma clients.
• Catalent: Catalent is a global CDMO with biologics and ADC development/manufacturing capabilities. Competes with Shilpa Biologicals for ADC drug substance and bioconjugate manufacturing work from pharma and biotech sponsors.
• AGC Biologics: AGC Biologics is a CDMO offering mammalian biologics, biosimilars, and bioconjugate services from facilities in Europe, the US, and Asia. Comparable in scope as a mid-to-large biologics CDMO targeting similar enterprise pharma customers.
• Biocon Limited: Biocon is an Indian-headquartered biopharmaceutical company with a leading biosimilars franchise and integrated biologics manufacturing. Comparable as an Indian biologics/biosimilar player targeting global enterprise pharma and biosimilar licensing partners.
• Piramal Pharma Solutions: Piramal Pharma Solutions is an Indian-headquartered CDMO with biologics, ADC payload, and contract manufacturing capabilities. Direct domestic competitor serving global pharma customers seeking integrated India-based CDMO services.
• Intas Pharmaceuticals: Intas Pharmaceuticals operates a biosimilars and biologics manufacturing platform (through Accord BioPharma and others) with global commercialization. Comparable as an Indian biosimilars manufacturer competing for similar enterprise pharma and licensing deals.
• Syngene International: Syngene International is an Indian CRO/CDMO offering biologics development and manufacturing services to global pharma. Comparable as an Indian-headquartered contract services provider targeting global enterprise pharma customers with biologics programs.

Broad incumbents

• Dr. Reddy's Laboratories (Biologics): Dr. Reddy's is a large Indian pharmaceutical company with a growing biologics and biosimilars business alongside its broad small-molecule portfolio. Comparable as an Indian biopharma serving global enterprise pharma customers with biosimilar products.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks5 records

Customer concentration

• LinkedInlinkedin.com/company/shilpa-biologicals-private-limited

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Shilpa Biologicals