What’s New

Carrying a

diverse range of

pharmaceutical expertise

Our R&D platform is designed to help pharma companies bring a wide range of products to the market faster. We combine scientific rigor, IP intelligence, and regulatory strategy to make it happen.

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Across formats

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From liposomes & emulsions that boost solubility and stability, to lyophilised products built for shelf life, to long-acting injectables and peptides with simpler dosing; we’ve worked across them all.

Across regulations

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We think about IP and regulatory pathways right from the start. That way, you’re strategically aligned for faster approvals, exclusivity opportunities, and reduced litigation risk.

Across formulation

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We go beyond generic replication to design clinically and commercially differentiated products with novel delivery, superior patient outcomes, and potential 505(b)(2) advantages.

Purpose-built

innovation hub

Invengene’s dedicated Injectable R&D Center in Thane, India covers 25,000+ sq. ft., built to turn complex ideas into real-world applications

Formulation laboratories

Purpose-built labs for experimenting with polymers, solvents, and various delivery systems.

Analytical development units

Equipped with ICH-aligned instrumentation for full-spectrum testing and validation.

Exhibit batch suites

Pilot-scale infrastructure to manufacture regulatory-ready batches for filing and scale-up at our global CMO network

Multi-Program Support

Ability to manage 10+ development programs concurrently with cross-functional team integratio

Sterilization Capabilities

Aseptic and terminal sterilization options designed to handle cytotoxics, emulsions, and high-potency APIs.

Purpose-built innovation hub

Invengene’s dedicated Injectable R&D Center in Thane, India covers 25,000+ sq. ft., built to turn complex ideas into real-world applications

Formulation laboratories

Purpose-built labs for experimenting with polymers, solvents, and various delivery systems.

Analytical development units

Equipped with ICH-aligned instrumentation for full-spectrum testing and validation.

Exhibit batch suites

Pilot-scale infrastructure to manufacture regulatory-ready batches for filing and scale-up at our global CMO network

Multi-Program Support

Ability to manage 10+ development programs concurrently with cross-functional team integratio

Sterilization Capabilities

Aseptic and terminal sterilization options designed to handle cytotoxics, emulsions, and high-potency APIs.

Core R&D
capabilities

Formulation Development
Analytical Development
Packaging Development
PK/PD & Clinical Trial Enablement

Extensive capabilities & integrated expertise

From molecule profiling to packaging readiness— all under one roof.

Formulation
development

From solubility enhancement to viscosity control, our scientists design high-performance formulations using advanced technologies and excipients tailored for complex injectables.

Analytical
Development

We support method development, validation, and release testing in line with ICH guidelines, with strong documentation for regulatory filings.

Packaging
Development

We evaluate the compatibility and performance of both primary and secondary packaging against stress factors like temperature, light, and chemical stability; ensuring container-closure integrity and global compliance.

PK/PD & Clinical
Trial Enablement

Through partner-enabled platforms, we support early-stage pharmacokinetic modeling, bioequivalence study planning, and clinical trial enablement, aligned to the requirements of the target submission market.

Extensive capabilities &integrated expertise
Core R&D capabilities

From molecule profiling to packaging readiness — all under one roof.

Formulation Development

Formulation
development

From solubility enhancement to viscosity control, our scientists design high-performance formulations using advanced technologies and excipients tailored for complex injectables.

Analytical Development

Analytical
Development

We support method development, validation, and release testing in line with ICH guidelines, with strong documentation for regulatory filings.

Packaging Development

Packaging
Development

We evaluate the compatibility and performance of both primary and secondary packaging against stress factors like temperature, light, and chemical stability; ensuring container-closure integrity and global compliance.

PK/PD & Clinical Trial Enablement

PK/PD & Clinical
Trial Enablement

Through partner-enabled platforms, we support early-stage pharmacokinetic modeling, bioequivalence study planning, and clinical trial enablement, aligned to the requirements of the target submission market.

Seamless compliance across borders

Health Canada
EU GMP
mhra
Sahpra
FDA
jordan
anvisa
Jumuiya afrika
australian govt
ukraine

A new-gen partner for

Filing first. Filing smart.

Global dossier expertise

ANDA, CTD, and eCTD-ready documentation for USFDA, EMA, ANVISA, SPHARA, and more.

Territory-specific compliance

Region-specific filing strategies and regulatory adaptations customized for our global presence

Integrated planning

Regulatory strategy integrated into product design to fast-track approvals.

Regulatory query handling

Proactive management of deficiencies, inspections, and submission support lifecycles.

Lifecycle mapping

Spot whitespace, weak patents, and exclusivity windows.

IP-First thinking

Build defensible differentiation via composition, use, and delivery format.

Competitive intelligence

Track the landscape in real time to guide formulation, territory, and filings.

Shared IP models

Enable joint development with flexible co-ownership frameworks.