Top CDMO in India for USA Pharmaceutical Companies
Global CDMO Services for the USA Pharmaceutical Market
At Shilpa Pharma, we support the USA pharmaceutical and biotech industry with globally trusted CDMO services delivered from India. As a recognized contract development and manufacturing organization, we partner with US-based innovators to provide compliant, scalable, and market-ready solutions tailored to regulated environments.
Our CDMO services for the USA market are backed by global regulatory approvals, including USFDA, EU GMP, PMDA, ANVISA, COFEPRIS, KFDA, and TGA. With advanced manufacturing infrastructure and strong quality systems, Shilpa Pharma enables USA pharmaceutical companies to meet regulatory, technical, and commercial objectives with confidence.
We offer end-to-end CDMO capabilities, spanning R&D, process development, formulation, scale-up, and commercial manufacturing. Our expertise includes oncology, high-potency APIs, specialty therapeutics, and complex chemistry, ensuring precision, confidentiality, and reliable timelines across every stage of development.
For USA pharmaceutical and biotech companies seeking dependable contract manufacturing organizations in India, Shilpa Pharma provides a strategic advantage through technical excellence, regulatory strength, and consistent supply performance for global markets.
OUR India CDMO SPECIALITIES
Advanced capabilities in chemical synthesis and manufacturing
High Pressure Reaction with Pd/Ru/Rd etc., Hydrogenation
Brominating / Chlorination
Cyanation
Electro-Chemical Reactions
Asymmetric Synthesis
Cryogenic Reactions (up to -90°C)
Boron Chemistry
Hydrogenation (Including Asymmetric Capabilities)
Use of Phase Transfer Catalyst
Cytotoxic (Onco) Products — Can Handle with Isolators
Butyl Lithium Reaction
Chiral Synthesis
Grignard Reaction
Indole Chemistry
Nucleoside Chemistry
Purine Chemistry
Pyridine Chemistry
Steroid Chemistry
Oxidation and Reduction Reactions
Pressure Reactions
Enzymatic Reactions
Explore Our Range of Products
To request a quote or learn more about our CDMO services in USA, please contact us.
Our Expertise at a Glance
Leading the Way in Pharma Innovation
1987
Established
100+
R&D workforce
1500+
Team size
3
Manufacturing site
100+
Audits
500+
Customers
100+
Projects
We are Largest CDMO in India Serving the USA – Full-Service CMO Contract Manufacturing
Shilpa Pharma is a globally trusted, India-based CDMO supporting pharmaceutical and biotech companies in the USA with reliable, high-quality contract development and manufacturing services. Recognized for scientific depth, regulatory strength, and manufacturing excellence, we partner with US-based innovators across the entire product lifecycle.
Our USFDA-compliant manufacturing facilities in India, supported by robust quality systems, enable seamless execution from small-batch development and scale-up to commercial production. We deliver consistent performance across complex APIs, specialty formulations, and advanced therapeutics, with a strong focus on precision, transparency, and regulatory adherence.
With proven expertise in process optimization, formulation development, and commercial manufacturing, Shilpa Pharma stands out as a full-service CMO contract manufacturing organization for the USA market. Our scalable, compliant, and cost-effective CDMO solutions help US pharmaceutical companies accelerate development while maintaining the highest global quality standards.
As a preferred CMO for global pharmaceutical innovators, Shilpa Pharma is committed to building long-term, strategic partnerships. Our flexible and customized CDMO solutions are designed around each molecule, development timeline, and regulatory pathway. From complex APIs and oncology programs to high-potency compounds and specialized formulations, our scientific teams enable smooth technology transfer, process optimization, and efficient scale-up.
Beyond manufacturing, Shilpa Pharma delivers added strategic value through deep technical expertise, reliable supply performance, and strict confidentiality. We work as a trusted extension of our partners’ operations, supporting development and commercialization with consistency and transparency.
For USA pharmaceutical and biotech companies seeking a dependable, high-performing CMO contract manufacturing organization, Shilpa Pharma stands out for its commitment to quality, speed, and collaborative execution—delivering results that meet the demands of regulated global markets.
Serving Clients Across The Globe
Learn About CMO Contract Manufacturing development in India to Unites States
Leading CDMO in India Serving the United States Pharmaceutical Market
Shilpa Pharma is a globally trusted, India-based Contract Development and Manufacturing Organization (CDMO) supporting pharmaceutical and biotech companies in the United States. Recognized for our quality-driven approach, regulatory excellence, and advanced manufacturing capabilities, we help US-based innovators accelerate development, optimize costs, and deliver high-quality medicines to regulated markets.
What Is a CDMO?
A CDMO (Contract Development and Manufacturing Organization) is a strategic partner that supports pharmaceutical and biotech companies across both drug development and manufacturing stages. CDMOs offer integrated services including formulation development, analytical testing, process optimization, API manufacturing, and commercial-scale production.
By partnering with a CDMO, pharmaceutical companies can focus on research, innovation, and market expansion while relying on an experienced organization to manage compliant, efficient, and scalable development and manufacturing processes. CDMOs play a critical role in accelerating timelines, reducing operational risk, and delivering regulation-ready medicines.
Why Choose Shilpa Pharma for CDMO Services for the USA Market?
Shilpa Pharma combines scientific expertise, regulatory strength, and proven manufacturing performance—making us a trusted CDMO partner for USA pharmaceutical and biotech companies. Our manufacturing facilities in India operate under stringent global quality standards and hold approvals from major regulatory authorities, including USFDA, EU GMP, PMDA, TGA, COFEPRIS, KFDA, and ANVISA.
What We Offer:
- End-to-end CDMO support from development through commercial manufacturing
- Expertise in complex APIs, oncology therapies, and high-potency compounds
- Robust quality systems with strict confidentiality and reliable supply performance
- Dedicated technical, analytical, and regulatory teams for seamless project execution
- Flexible and scalable CDMO solutions tailored to molecule-specific and market needs
Whether you require specialized development services or commercial-scale manufacturing, Shilpa Pharma delivers precision, efficiency, and consistent quality for regulated markets.
Your Trusted Global CDMO Partner for the USA Market
For USA pharmaceutical and biotech companies seeking a dependable CDMO partner, Shilpa Pharma offers transparent processes, advanced technologies, and world-class manufacturing designed to support long-term growth and regulatory success.
Ready to collaborate with a trusted global CDMO?
Connect with Shilpa Pharma today to explore customized CMO and CDMO solutions tailored for the USA pharmaceutical market.