What Stelis Biopharma does

OneSource (the operating brand of Stelis Biopharma) is a Bangalore, India-headquartered multimodal pharmaceutical Contract Development and Manufacturing Organization (CDMO) that delivers end-to-end services spanning process development, technology transfer, scale-up, and commercial manufacturing. It positions itself as a single-contract alternative to multi-vendor outsourcing models, with the explicit value proposition of reducing operational interfaces for pharmaceutical and biologics sponsors.

The portfolio rests on four core capability pillars: Drug-Device Combinations (over 20 automatic and semi-automatic flexible assembly stations supporting prefilled syringes, dial-and-push variable and fixed-dose pen injectors, pull-push fixed-dose pens, and autoinjectors); Sterile Injectables (35 approved US ANDAs, 19 commercialized US drug products, and capabilities across sterile liquids, lyophilized vials, prefilled syringes, and dry powder injections); Complex Biologics (integrated process and analytics development with dedicated tech-transfer and scale-up resources); and Soft Gelatin Capsules (capacity of up to 2.4 billion capsules annually in multiple formats, shapes and sizes). Operations are consolidated in one state-of-the-art, multi-regulatory-body-approved facility, supported by 23+ scientists and techno-commercial leaders with seven years of operational and regulatory compliance track record.

Commercially, the business runs on an enterprise field-sales motion targeting pharmaceutical and biologics developers seeking complex dosage-form manufacturing, with a horizontal segmentation approach across use cases rather than therapeutic areas. Pricing is not publicly disclosed and is project/quote-based, consistent with CDMO contracting norms. The company maintains an investor-relations function including financial reports, stock-exchange intimation, and disclosures under Regulation 46 LODR, alongside active reference to two successive Schemes of Arrangement (2024 and 2025), signaling ongoing corporate restructuring. Distribution and demand generation mix a capabilities-focused website, conference participation (notably CPHI Frankfurt 2025), and direct enterprise outreach — with no named customers, channel partners, or distributor network disclosed in the available material.

Name

Stelis Biopharma

Legal name

OneSource

Website

https://stelis.com

Company type

Private

Operating status

Operating

Headcount range

501–1,000 employees

Short description

OneSource (Stelis Biopharma) is a Bangalore-based multimodal pharmaceutical CDMO offering end-to-end drug development and manufacturing across drug-device combinations, sterile injectables, complex biologics, and soft gelatin capsules for pharmaceutical and biologics sponsors.

Ownership category

akta.pro rank

Product category

Pharmaceutical CDMO Services

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Drug Substance–Drug Product Integrated CDMO (HLAGABAG)

akta.pro secondary industries

Sterile Fill-Finish & Aseptic Manufacturing CDMO (HLAGABAH), Fill-Finish & Aseptic Drug Product Manufacturing (Biologics/ATMP) (HLAGAGAG), Biologic API/Drug Substance Manufacturing Services (HLAAAKAA), Aseptic Processing, Fill-Finish & Sterile Manufacturing Tech (isolators, lyophilization interfaces) (HLAAAJAG), Specialty Injectable & Infusion Therapies (Cross-therapeutic) (HLAIACAO)

Keywords

• Contract pharmaceutical manufacturing
• Biologics development services
• Sterile injectables manufacturing
• Drug-device combination products
• Soft gelatin capsule production

Headquarters

HQ city

Not specified in source

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, Marketing or Sales

Revenue model

1. Contract Manufacturing Services: As a CDMO, OneSource generates revenue through contract development and manufacturing services for pharmaceutical and biologics products, providing end-to-end solutions from development to commercialization.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Stelis Biopharma, operating through its brand OneSource, is a multimodal specialty pharmaceutical and biologics Contract Development and Manufacturing Organization (CDMO) delivering end-to-end drug development and manufacturing across four capability platforms: drug-device combinations (prefilled syringes, pen injectors, autoinjectors), sterile injectables (liquids, lyophilized vials, prefilled syringes, dry powder injections), complex biologics (process and analytics development, tech transfer and scale-ups), and soft gelatin capsules (up to 2.4 billion capsules annually). Services are delivered under a single-contract model from one state-of-the-art, regulatory-approved facility to reduce clients' operational interfaces across the product lifecycle.

Product overview

OneSource is a multimodal specialty pharma CDMO (Contract Development and Manufacturing Organization) offering end-to-end capabilities across tech platforms and therapeutic modalities. The portfolio consists of four core service/product areas: Drug-Device Combinations (with flexible assembly stations for prefilled syringes and pen injectors), Sterile Injectables (with 35 approved ANDAs and 19 commercialized products), Complex Biologics (integrated process and analytics development), and Soft Gelatin Capsules (producing up to 2.4 billion capsules annually). These offerings are unified under a single contract model to provide comprehensive drug development and manufacturing solutions.

Differentiator

Problem solved

Functional benefit

Products and services

• Drug-Device Combinations Contract manufacturing services for drug-device combination products, including prefilled syringes, dial-and-push variable and fixed dose pen injectors, pull-push fixed dose pens, and autoinjectors, supported by over 20 automatic and semi-automatic flexible assembly stations and tailored to client-specified device formats.
• Sterile Injectables Contract development and manufacturing of complex sterile injectable drug products in multiple dosage forms, including sterile liquids, lyophilized vials, prefilled syringes, and dry powder injections, backed by 35 approved ANDAs and 19 commercialized drug products in the United States.
• Complex Biologics Integrated contract development solutions for complex biologics combining flexible infrastructure, advanced technologies, and extensive capacity with process and analytics development and a dedicated team for tech transfer and scale-ups.
• Soft Gelatin Capsules High-volume contract manufacturing of soft gelatin capsules producing up to 2.4 billion capsules annually in multiple formats and various shapes and sizes, using rapid and efficient production processes for high-quality softgel products.

Quantifiable outcome

• 35 approved Abbreviated New Drug Applications (ANDAs) in the United States
• +3 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Scale indicators6 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Piramal Pharma Solutions: India-headquartered CDMO offering sterile injectables, drug-device combinations, and biologics manufacturing with global regulatory footprint. Closely comparable to OneSource in modality mix, customer base (US generic and innovator sponsors), and integrated CDMO positioning.
• Syngene International: Bengaluru-based contract research, development and manufacturing organization serving global pharma with biologics manufacturing capabilities. Comparable as an India-headquartered, publicly listed CDMO with similar enterprise customer base.
• Jubilant Pharmova: Indian integrated pharma and CDMO with sterile injectables, APIs, and biologics capabilities. Comparable as a domestic competitor in similar dosage forms and end-to-end development-to-commercial services for global sponsors.
• Suven Pharmaceuticals: Indian CDMO focused on complex APIs and contract development/manufacturing for global pharma. Comparable as an India-based, publicly listed mid-sized CDMO serving innovator and generic sponsors with regulated manufacturing capabilities.
• Neuland Laboratories: India-based CDMO specializing in APIs and peptide manufacturing with US FDA-approved facilities. Comparable as a smaller Indian publicly listed CDMO competing for similar pharma sponsor outsourcing contracts.

Broad incumbents

• Samsung Biologics: South Korea-based pure-play biologics CDMO with very large single-site mammalian cell culture capacity. Comparable in biologics CDMO segment and as a major single-facility operator, though focused exclusively on biologics rather than OneSource's multimodal mix.
• Lonza Group: Swiss-based global CDMO leader in biologics, cell and gene therapy, and small molecule manufacturing. Comparable as a broad incumbent with overlapping biologics and fill-finish capabilities, though at much larger scale and across multiple sites.
• WuXi AppTec / WuXi STA: China-based global CRO/CDMO with substantial small molecule, biologics, and sterile injectable capacity. Comparable as a broad incumbent in integrated CDMO services, though operating at significantly larger scale.
• Catalent: Global CDMO leader in softgel, sterile injectables, and drug-device combinations, now owned by Novo Holdings. Comparable as a broader incumbent offering many of the same modalities at significantly larger scale across multiple geographies.

Regional players

• Aurobindo Pharma: India-based vertically integrated generic pharma manufacturer with significant US ANDA approvals and injectable manufacturing. Comparable as a domestic competitor with similar US generic commercialized product footprint, though primarily a product company rather than pure CDMO.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/stelisbiosource

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Stelis Biopharma