What Steps Biosciences does

Steps Biosciences is a virtual sterile product development company incorporated in Delaware, USA in September 2018, with operational headquarters in Bengaluru, India via its wholly-owned subsidiary Steps Bio India Pvt Ltd. The company develops complex small-molecule sterile products under two regulatory pathways — generic equivalents (ANDA) and differentiated formulations (505(b)(2)) — for both human and veterinary applications, with a portfolio spanning depot/long-acting injectables, nano-formulations (nano-emulsions and nano-suspensions), controlled-substance sterile products, high-containment products (oncology, steroids, hormones, antibiotics), and conventional injectable and ophthalmic sterile dosage forms.

Rather than operating its own manufacturing facilities, Steps Bio executes development through a global network of contract research and contract manufacturing organizations (CROs/CMOs), which keeps capex requirements low and allows flexible scaling. Its revenue model combines co-development partnerships (shared costs and IP with development-fee and milestone revenue) with out-licensing of developed sterile product portfolios (upfront payments, milestones, and royalties) directed at pharmaceutical companies, biotechnology firms, academic and research institutions, and veterinary pharmaceutical companies.

The leadership and advisory bench is the company's most differentiated asset: co-founders include the former COO of Syngene International (Manoj Nerurkar) and the former SVP and head of injectable R&D at Dr. Reddy's Laboratories (Harshal Bhagwatwar, who led development of 30+ sterile products), supported by a CFO and CCO with Big Pharma/generics backgrounds and advisors including the former VP/Global Head of Pharmaceutical R&D at Bayer. In June 2026, Steps Bio established a Centre of Excellence (GSRC) with GV Research Platform (GVRP) inside Bengaluru's 1BLR Life Sciences Cluster to anchor its formulations R&D footprint in India's life-sciences ecosystem.

Name

Steps Biosciences

Legal name

Steps Biosciences, Inc

Website

https://stepsbio.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

Steps Biosciences is a virtual sterile product development company developing generic equivalents (ANDA) and differentiated formulations (505(b)(2)) — including depot, nano-formulation, controlled-substance, and containment sterile products — for pharmaceutical, biotech, academic, and veterinary clients via co-development partnerships and out-licensing.

Ownership category

akta.pro rank

Product category

Sterile Pharmaceutical Product Development

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)

SIC

Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

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

Keywords

• Sterile product development
• Complex generic injectables
• Pharmaceutical co-development
• Differentiated sterile formulations
• 505(b)(2) drug development

Headquarters

HQ city

Saint Georges

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. Co-development Partnerships: Joint development of sterile products with pharmaceutical partners where costs and intellectual property are shared, generating revenue through development fees and milestone payments.
2. Product Out-licensing: Licensing of developed sterile product portfolios to pharmaceutical companies for commercialization, generating revenue through upfront payments, milestone payments, and royalties.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels3 records

Core offering

Steps Biosciences is a sterile product development company that develops complex generic equivalents (ANDA) and differentiated formulations (505(b)(2)) for human and veterinary applications. Operating as a virtual organization, it leverages a global partner network of CROs and CMOs to deliver depot formulations, nano-formulations, controlled substance sterile products, high-containment products, and conventional injectables and ophthalmics through co-development partnerships and out-licensing.

Product overview

Steps Biosciences is a small molecule, sterile product development company developing both generic equivalents (ANDA) and differentiated formulations (505(b)(2)) to solve unmet medical needs. The company operates as a virtual organization leveraging a global partner network of CROs and CMOs. Its portfolio spans multiple sterile dosage form categories: depot formulations, controlled substance products, nano-formulations (nano-emulsions and nano-suspensions), containment products for oncology/steroids/hormones/antibiotics, and conventional injectable and ophthalmic products. Steps Biosciences supports both human and veterinary applications.

Differentiator

Problem solved

Functional benefit

Products and services

• Co-development partnerships for sterile products
• Out-licensing of sterile products portfolio
• Generic equivalents (ANDA) sterile products
• Differentiated formulations (505(b)(2)) sterile products
• Veterinary sterile products

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• GV Research Platform (GVRP)coreStrategic or Co-development Partner · 6 June 2026Hyderabad-based GV Research Platform (GVRP) and Bengaluru-based Steps Biosciences partnered to establish a Centre of Excellence (CoE) for formulations research and development, named GSRC, located within the Lifescapes campus at the 1BLR Life Sciences Cluster in Bengaluru. The facility aims to advance pharmaceutical formulations R&D, support complex drug development programmes, and foster collaboration among pharmaceutical companies, biotech firms, researchers, and academic institutions. The launch reinforces Bengaluru's position as a leading life sciences hub and strengthens India's capabilities in the global pharmaceutical and formulation research sector.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Alcami Corporation: US-based CDMO specializing in sterile injectable development and manufacturing for pharma and biotech. Directly comparable as a contract development organization focused on complex sterile dosage forms serving similar pharmaceutical and biotech customers.
• Pharmaceutics International Inc (Pii): Sterile injectable development and manufacturing CDMO with capabilities in complex formulations and aseptic fill-finish. Comparable as a specialized sterile injectables CDMO serving similar pharma and biotech partner base with development and manufacturing services.
• Gland Pharma: India-based injectable-focused pharmaceutical company with strong sterile injectables portfolio and CDMO capabilities. Comparable as a sterile injectables specialist with co-development and licensing business model serving global pharma partners.
• Amphastar Pharmaceuticals: Specialty pharmaceutical company focused on injectable and inhalation products with complex formulation capabilities. Comparable as a sterile injectables specialist pursuing generic and differentiated formulations with limited internal manufacturing.
• Syngene International: India-based CRO/CDMO offering integrated discovery, development, and manufacturing services to global pharma. Comparable given Steps Bio co-founder Manoj Nerurkar served as Syngene's COO; both serve pharmaceutical and biotech clients with formulation and development services from India.

Broad incumbents

• Hikma Pharmaceuticals: Global pharmaceutical company with major sterile injectable franchise including specialty and complex generics. Comparable as a broad incumbent with deep sterile injectables portfolio pursuing both generic (ANDA) and differentiated formulations across multiple therapeutic areas.
• Catalent: Large global CDMO with extensive sterile injectable development and manufacturing capabilities. Comparable as a broad incumbent offering end-to-end sterile drug product development services to pharma and biotech, though operating at significantly larger scale.
• Recipharm: European CDMO with sterile injectable fill-finish and development capabilities. Comparable as a broad CDMO incumbent offering sterile drug product development services to global pharma partners, including complex generics.
• Endo International (Sterile Injectables): Specialty pharmaceutical company with significant sterile injectable franchise including generics and proprietary products. Comparable as a broad incumbent in complex sterile injectables with both development and commercialization capabilities.

Regional players

• Sai Life Sciences: India-based CRO/CDMO offering drug discovery, development, and manufacturing services to global pharma and biotech. Comparable as an India-based peer offering formulation and development services in the same regional ecosystem, though with broader discovery focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/steps-biosciences-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

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 Steps Biosciences