The CDMO Industry in India
Over the past decade, there has been a significant change in the development and production of pharmaceuticals. Quicker timelines, stringent rules, higher prices, and increased expectations from both patients and regulators put pharmaceutical companies under constant strain.
Many businesses are no longer attempting to handle everything internally to cope with this. Rather, companies are opting to collaborate closely with CDMOs, Contract Development and Manufacturing Organizations that emphasize flexibility, speed, compliance, and innovation. A Contract Research and Manufacturing Organization (CDMO) offers a wide range of services, including:
- Drug Development (Formulation, API Synthesis, Analytical Testing)
- Commercial-scale Manufacturing (Both APIs and finished dosage forms)
- Clinical Trial
- Regulatory Support (ANDAs, DMFs, INDs)
- Packaging & Logistics
In this change, India's CDMO sector has subtly emerged as one of the key pillars sustaining the expansion of the pharmaceutical business & global supply chains. Its cost competitiveness, skilled workforce, and regulatory compliance make it a preferred destination for global pharma companies.
Market Overview
According to Grand View Horizon, India’s CDMO Industry market was valued at USD 13.5 billion in 2024 and is projected to reach USD 27.9 billion by 2033, growing at a CAGR of 8.4% between 2025 and 2033.
According to Business Standard, India has over 650 USFDA-approved manufacturing facilities, reflecting its strong regulatory compliance and manufacturing depth. Strengthening this position, CareEdge (2025) highlights that India ranks second globally in the number of USFDA-approved facilities. About 35% of India's pharmaceutical exports were sent to the US in FY25, as the US is the biggest pharmaceutical market in the world and a significant consumer of Indian generic medications.
Key growth drivers:
1. Cost Efficiency (~30-40% lower costs).
2. Strong Scientific & Technical Expertise.
3. Strong Regulatory Track Record (USFDA, EMA, MHRA, and WHO-GMP).
4. Global Supply Chain.
5. Vertical Integration (End-to-end solutions).
Astonea Labs: India’s Trusted CDMO Partner
Within this rapidly growing landscape, Astonea Labs is significantly contributing to strengthening India’s position as a reliable global CDMO partner. As a comprehensive pharmaceutical CDMO in India, Astonea Labs delivers adaptable, compliant, and scalable solutions customized for the requirements of international pharmaceutical and healthcare companies.
Astonea Labs provides expertise in:
Formulation development and optimization.
Contract manufacturing of finished dosage forms.
Regulatory-compliant production for international markets.
Scalable manufacturing from pilot to commercial volumes.
What sets Astonea Labs apart is its customer-focused CDMO approach. The company uses quality-driven processes with operational flexibility, the company enables clients to shorten development timelines, manage costs efficiently, and meet strict regulatory requirements.
With manufacturing practices aligned to international quality standards, Astonea Labs supports pharmaceutical companies looking to enter or expand in regulated and semi-regulated markets. Its collaborative project management model ensures transparency and reliability—key expectations in today’s global pharma outsourcing landscape.
Conclusion: India as a Global Pharma Partners
Thanks to its robust regulatory reputation, technical know-how, and expandable infrastructure, India’s CDMO industry is becoming a strategic growth partner for global pharmaceutical companies. Astonea Labs, a leading pharmaceutical CDMO in India, exemplifies this evolution—providing reliable, compliant, and flexible CDMO solutions that help international pharma brands succeed in an increasingly complicated and competitive healthcare industry.