From Generics to Complex Formulations: How Indian CDMOs Support Innovation

Introduction

While India's strengths in generic pharmaceutical products are well established, the market has also progressed far beyond that level. Today, Indian Contract Development and Manufacturing Organisations (CDMO's) are able to support the formulation of highly complex, advanced, and valuable products within the global pharmaceutical space. Combining R&D expertise with talented and skilled scientists, and low-cost development, Indian-based CDMO's provide excellent opportunities for companies seeking to create or improve their portfolios.

This guide provides insights into the ways in which Indian CDMO's can assist their global partners in the transition from simple generic formulations to more advanced and complex formulations. (Related: Why Global Pharma Companies Prefer India for CDMO Services)

1. Moving Beyond Generics: India’s New Capabilities

India has advanced in capabilities beyond those of generic pharmaceuticals to now provide services related to the development of:

• Complex chemistry
• Modified-release technology
• Novel drug delivery systems
• High-potency development
• Sterile processing
• Analytical method development

An increasing number of global pharmaceutical companies use Indian-based CDMO's not only for drug manufacturing but also for formulation development.

2. NDDS: Novel Drug Delivery Systems

Indian CDMOs work on advanced delivery systems that improve patient compliance and drug performance:

• Sustained release (SR)
• Controlled release (CR)
• Orally disintegrating tablets (ODTs)
• Transdermal systems
• Nasal sprays & inhalation products
• Liposomal formulations

These systems help companies extend product lifecycle and improve therapeutic outcomes.
 

3. Modified & Controlled Release Formulations

Indian CDMOs excel in:

• Matrix-based systems
• Multi-particulate bead systems
• Coated pellets
• Osmotic release tablets

These technologies allow tighter control over drug release and reduce dosing frequency.
 

4. Complex Injectables: Oncology & Specialty Products

Many Indian facilities now produce high-value sterile products, including:

• Oncology injectables
• Lyophilized injections
• Pre-filled syringes
• Hormonal injectables
• High-potency formulations (HPAPI)

These facilities follow strict sterile and containment standards, often with EU-GMP, USFDA, or WHO-GMP approval.
 

5. Ophthalmic, Nasal, and Inhalation Products

These dosage forms need high precision and specialized equipment.

Indian CDMOs support:

• Sterile ophthalmic solutions
• Nasal sprays
• Metered-dose inhalers (MDIs)
• Dry powder inhalers (DPIs)

This helps global companies add new product lines without investing in expensive infrastructure.

India is also growing in biosimilar development, including:

• Monoclonal antibodies
• Recombinant proteins
• Insulin analogs
• Oncology biologics

While this segment is still growing, India offers an attractive cost advantage for biologics manufacturing and fill-finish services.

7. Analytical & Regulatory Expertise

Complex formulations require strong analytical capability. Indian CDMOs provide:

• Method development
• Impurity profiling
• Forced degradation studies
• Stability studies
• Validation packages
• CTD/ACTD dossier support

This helps partners move quickly from R&D to commercial registration. (Related: How Indian CDMOs Comply with USFDA, EU-GMP, and WHO-GMP Standards)

8. End-to-End Innovation Support

Indian CDMOs help global companies throughout the product lifecycle:

This full-service model allows companies to outsource entire innovation pipelines.

9. Why Global Pharma Companies Prefer Indian CDMOs

Global companies choose Indian CDMOs for:

• Expert scientists at competitive cost
• Fast formulation development
• Flexible MOQs
• Strong compliance history
• Experience with USFDA, EU-GMP, MHRA, TGA
• Ability to support niche and specialty products

India offers the right balance of innovation, quality, and affordability. (Related: Cost Advantage & Innovation: India’s Competitive Edge in Pharma CDMO)

Conclusion

India is no longer considered only a generic pharmaceutical drug supplier. Indian CDMO's are now essential partners in the development of innovative pharmaceutical solutions for global pharmaceutical companies. With the technical capability, scale, and cost advantages provided by Indian-based CDMO's, global pharmaceutical companies can accelerate their ability to develop the next generation of complex formulations including injectables and novel drug delivery systems.

Global pharmaceutical companies looking to expand their pipelines or enhance existing formulations should view Indian CDMO's as being among the best worldwide. (Related: 50+ Leading CDMO Companies in India for Pharma Sourcing)