MSN’s API R&D is the foundation of our innovation engine, delivering best-in-class active pharmaceutical ingredients across a broad spectrum of therapeutic areas. With a deep focus on complex chemistry, novel synthesis pathways, and scalable technologies, our API research has empowered us to be the partner of choice for global pharmaceutical leaders.

Speciality

High-potency APIs

Prostaglandins

Peptides

Oligonucleotides

Organic small molecules

Hormones

Carbohydrates

Complex chemistry

Pioneers in novel process routes, polymorphs, co-crystals, and salt forms.

Leaders in first-to-file USDMFs, driving early market access for partners.

Proven lifecycle management and strong patent strategies for sustainable affordability.

Infrastructure

Chemical Process R&D Labs

22 dedicated labs working on early-stage development to scalable synthesis. These labs are designed to handle multi-step complex reactions with advanced containment measures for high potent molecules.

Analytical R&D Labs

11 analytical labs supported by two sophisticated instrumentation centers. These labs ensure robust analytical method development, validation, impurity profiling, and stress testing.

Specialized Labs

Dedicated R&D labs for peptides, biotechnology, oligonucleotides, Hormones, Iron Complexes, Polymorph screening labs, and preparative HPLC purification. Equipped with SPPS units of 25L, 100L, and 500L for solid-phase synthesis and peptide scale-up.

KG Lab (Pilot Plant)

A fully equipped pilot facility with over 30 reactors (ranging from 50L to 650L), designed for scale-up studies and process optimization before commercial transfer. Ensures smooth transition from lab to plant.

Capabilities

Analytical API R&D (AR&D)
Focuses on method development, validation, polymorph screening, stability studies, and nitrosamine assessment. Ensures accurate characterization, regulatory compliance, and alignment with pharmacopeias.
Project Management (PM)
Coordinates end-to-end execution across development stages with defined stage-gate control. Ensures timely project delivery from feasibility, tech transfer, to DMF filing.
Intellectual Property Management
Coordinates end-to-end execution across development stages with defined stage-gate control. Ensures timely project delivery from feasibility, tech transfer, to DMF filing.
Development Quality Assurance
Maintains documentation integrity, regulatory compliance, and ensures all processes follow GMP guidelines during development and transfer phases.
Regulatory Affairs (RA)
Expert team with deep understanding of global regulations. Handles document compilation, regulatory submissions (USDMF, CEP, etc.), and timely response to agency queries.

1300+

Drug Master Files (DMFs)

2,500+

Dossiers

200+

ANDAs registered

Reports

The Sustainability Report of the MSN group of Companies reflects the group’s commitment to incorporate environmental, social, and governance (ESG) consideration into its operations and decision making processes. Download the sustainability report 2023 & 2024

Sustainability Report