CDMO Services in India

End-to-End CDMO Services in India by Shilpa Pharma

At Shilpa Pharma, we offer comprehensive Contract Development and Manufacturing Organization (CDMO) services in India, enabling global pharmaceutical and biotechnology companies to accelerate the development and commercialization of high-quality products. As a globally trusted CDMO pharma company, we specialize in drug substance manufacturing, formulation development, biologics, and customized contract manufacturing solutions that comply with the most stringent international regulatory and quality standards.

Whether you require fully integrated, end-to-end CDMO services across the entire drug lifecycle or specialized CDMO biologics support, Shilpa Pharma delivers flexible, scalable, and cost-effective solutions tailored to your specific development, regulatory, and commercial objectives.

What is CDMO?

A Contract Development and Manufacturing Organization (CDMO) is a strategic partner that provides end-to-end pharmaceutical development and manufacturing services to pharma and biotech companies. CDMOs support every stage of the drug lifecycle, including formulation development, clinical trial material manufacturing, process scale-up, and commercial production.

By partnering with a reliable CDMO pharma company, organizations can focus on their core strengths such as drug discovery, innovation, and market expansion, while leveraging the CDMO’s advanced infrastructure, scientific expertise, and regulatory capabilities to ensure faster timelines and consistent quality.

Why International Companies Choose CDMO in India?

India has emerged as a global hub for CDMO and contract manufacturing services due to its strong scientific ecosystem, regulatory maturity, and cost competitiveness. International pharmaceutical companies increasingly prefer CDMO services in India for the following reasons:

• High-Quality Standards: Indian CDMOs operate in compliance with global regulatory frameworks such as US FDA, EMA, and other international authorities, ensuring world-class product quality.
• Cost Advantage: India offers significant cost efficiencies compared to US and European markets, without compromising on technology, compliance, or quality.
• Skilled Workforce: Access to a large pool of highly qualified scientists, chemists, and engineers with deep expertise in R&D and large-scale pharmaceutical manufacturing.
• Strong Regulatory Ecosystem: Multiple USFDA-approved and EU GMP-certified manufacturing facilities enable seamless access to regulated global markets.
• Integrated Capabilities: Leading Indian CDMOs like Shilpa Pharma provide end-to-end services from early development to commercial supply.

Advantages of CDMO Services

Partnering with a trusted CDMO pharma company in India offers several strategic and operational advantages:

• Accelerated Time-to-Market: Streamlined development and manufacturing processes significantly reduce product launch timelines.
• Scalability and Flexibility: Seamless transition from small clinical batches to large-scale commercial manufacturing.
• Regulatory Expertise: In-depth knowledge of global regulatory requirements ensures smooth approvals and compliance.
• Innovation Support: Access to advanced technologies, specialized R&D infrastructure, and novel drug delivery platforms.
• Risk Mitigation: Shared technical, regulatory, and manufacturing responsibilities reduce development and scale-up risks.
• Cost Optimization: Outsourcing to a CDMO eliminates the need for heavy capital investment in in-house infrastructure.

Global Regulatory Approvals and Compliance

As a globally recognized CDMO in India, Shilpa Pharma operates manufacturing facilities designed to meet the highest international quality and compliance benchmarks. Our state-of-the-art plants hold multiple global certifications, ensuring that products manufactured in India are readily accepted in regulated and semi-regulated markets worldwide.

Our facilities are approved by:

• US FDA Approved (United States Food & Drug Administration)
• EU GMP Certified (European Union Good Manufacturing Practice)
• ANVISA Approved (Brazil)
• COFEPRIS Approved (Mexico)
• TGA Certified (Australia)
• PMDA Approved (Japan)
• KFDA Certified (South Korea)

These approvals reinforce Shilpa Pharma’s position as a trusted CDMO pharma company capable of delivering APIs and finished dosage forms that meet the highest standards of safety, efficacy, and quality.

Why Choose Shilpa Pharma for CDMO in India?

Shilpa Pharma is a leading CDMO in India, recognized globally for its commitment to quality, innovation, and regulatory excellence. With decades of experience, we offer comprehensive contract development and manufacturing services across multiple therapeutic areas and dosage forms.

Our key strengths include:

• Comprehensive Expertise: From formulation development and process optimization to complex API manufacturing and finished dosage production.
• Advanced Infrastructure: State-of-the-art R&D and manufacturing facilities equipped for small molecules, biologics, and complex therapies.
• Global Regulatory Acumen: Proven track record of successful approvals across regulated and semi-regulated markets.
• Uncompromising Quality: Stringent cGMP-compliant processes and robust quality control systems.
• Strategic Partnerships: Collaborative, transparent, and client-focused approach aligned with long-term business goals.
  
  

Trusted by Global Markets

Shilpa Pharma is the preferred CDMO partner for pharmaceutical companies across China, Japan, Europe, and other international markets. Our global reputation is built on consistent quality, strong compliance systems, and responsive customer support.

Partner with Shilpa Pharma – Your Trusted CDMO Partner in India

Looking for a contract manufacturing organization in India that combines innovation, regulatory compliance, and reliability? Partner with Shilpa Pharma for end-to-end CDMO services in India. From advanced R&D and drug development to large-scale API manufacturing and finished dosage production, we support your pharmaceutical journey with confidence, speed, and excellence.