Dr. Reddy’s API Research and Development Capabilities
Our commercial API facilities are equipped with state-of-the-art infrastructure, optimized through years of process innovation. Supported by multi-purpose plants for key starting materials and intermediates, we ensure stringent quality control and seamless regulatory compliance across global markets.
All facilities are approved by USFDA and certified by major regulatory bodies including:
WHO-GMP, MHRA, EMA, TGA, ANVISA, PMDA, COFEPRIS, and more.
Furthermore, our pharma research and development expertise has enabled us to develop a strong portfolio in key therapy areas, including oncology, cardiovascular, central nervous system, gastrointestinal system, etc.
R&D Centers – Driving Innovation
Our advanced R&D capabilities in synthetic chemistry, analytical chemistry, and process engineering drive a differentiated portfolio of small molecule APIs, including:
- High Potent APIs
- Complex APIs
- Prostaglandins & Steroids
- Synthetic & Semi-Synthetic Products
R&D Capabilities That Set Us Apart
- Route scouting & process optimization
- QbD implementation
- Solid-state characterization & polymorph screening
- Chiral chemistry, biocatalysis & chemo-catalysis
- Expertise in pharmaceutical development and technology
Innovation Guided by Sustainability Framework
Since 2010, Dr. Reddy’s has been a proud signatory of the UN Global Compact, upholding its principles in environmental responsibility, green chemistry, and sustainable development.
As a leading API supplier, our mission is to deliver high-quality, reliable APIs through eco-friendly processes ensuring our partners can access sustainable solutions without compromising on quality.
Our R&D teams integrate green chemistry principles into process development, optimizing technologies to reduce environmental impact while maintaining regulatory excellence and global supply reliability.
Our R&D Capabilities - Complex API’s and Services Supporting Early Market Entries
Experience with complex APIs and formulations (such as Eribulin, Fondaparinux, Iron compounds, etc.)
Innovative drug delivery platforms such as microspheres, liposomes, nanoparticles, etc.
Multiple IP-driven formulations for early launch opportunities.
Robust technology platforms such as synthetic/semi- synthetic peptides, chiral chemistry.
New formulations - e.g., ready to use.
Steroids, semi- synthetic/fermentation, unnatural amino acids, prostaglandins, pegylation technology. and flow chemistry
Advanced R&D Meets Regulatory Excellence
Our cGMP-compliant isolator systems enable safe handling of high-potent materials (OEL ≤ 0.1 µg/m³) across charging, filtration, drying, dispensing, and packaging ensuring protection of people, product, and environment.
R&D-Driven Innovation
- Proven expertise in nitrosamine-free process development, aligned with EMA’s evolving standards (<0.03 ppm for NDEA/NDMA)
- Strong capabilities in chromatography, QbD-based development, and impurity profiling
- Advanced purification, downstream isolation, and solid-state characterization
- Application of PAT tools (e.g., NIR-based gradient systems) for chromatography and lyophilization
Our experienced API and formulation teams provide end-to-end support, ensuring successful product development and regulatory alignment.
Going Beyond APIs with Generic Formulation Offerings to Complement Your Capabilities
We are vertically integrated from producing APIs to formulations.
Highly experienced and integrated technical team to support from filing-to-launch.
Backed by one of the best manufacturing bases in India for a seamless execution.
Super specialty products in therapy areas such as Central Nervous System (CNS), cardiovascular, and Oncology (Oral and Injectable)
Models of Collaboration:
Dossier + API supply
Dossier + Formulation supply
Dossier + Tech Transfer + API supply
Semi-finished product supply
To know more about our products or order a sample, meet with our product experts in one-on-one virtual sessions here. For details on the offer ability of products for your market of interest, please reach out to us at [email protected].
FAQs
- Our capabilities include contained (Highly potent APIs) and non-contained APIs at laboratory, pilot and production scales. We have the expertise to perform standard chemical reactions, route scouting, process development and optimization, QbD implementation, solid state characterization, polymorph screening, chiral chemistry, biocatalysis and chemocatalysis.
- Complemented by a fully integrated expertise across key starting materials, intermediates, and APIs, we are able to accelerate the time to market for our customers.
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As an integrated HPAPI supplier, we have the best in class infrastructure and practices for R&D and cGMP manufacturing. We enable best safety, health and environmental practices through Occupational Exposure Band (OEB) and Occupational Exposure Limit (OEL) based controls for workers, material, machines and environment.
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- We have expertise in complex multi-step carbohydrates involving linear and convergent synthesis.
- We also have the downstream capability to purify and isolate carbohydrates involving water soluble intermediates.
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With a dedicated facility for human and veterinary steroids, we have expertise in multi-step reactions, multiple module manufacturing, availability of stainless steel, glass-lined and Hastelloy C® reactors.
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Descargo de responsabilidad
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