CDMO Services for USA
US FDA-Compliant Contract Development & Manufacturing from India
Our CDMO Specialties
- 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
- Butyl Lithium Reaction
- Chiral Synthesis
- Cyclopropane Chemistry
- Grignard Reaction
- Indole Chemistry
- Nucleoside Chemistry
- Purine Chemistry
- Pyridine Chemistry
- Pyrimidine Chemistry
- Steroid Chemistry
- Oxidation and reduction reactions
- Pressure reactions
- Enzymatic reactions
- Use of phase transfer catalyst
- Cytotoxic (Onco) products Can handle with isolators.
Contact for End-to-End CDMO Services in India
Happy Customers
Projects Successfully Completed
Established
PhD Experts Driving R&D Excellence
Team Size
World-Class API Manufacturing Sites
Global Audits Successfully Completed
Comprehensive CDMO Service Offerings
Regulatory Affairs & Quality Compliance for the USA
Shilpa Pharma’s facilities are certified by major international regulatory authorities, demonstrating our commitment to quality and compliance. These global accreditations make Shilpa Pharma a preferred CDMO partner for German pharmaceutical companies seeking internationally compliant manufacturing and documentation support.
Why US Companies Choose Shilpa Pharma as Their CDMO Partner
As a globally accredited CDMO, Shilpa Pharma delivers end-to-end, compliant, and cost-effective solutions backed by expertise in complex chemistries and advanced formulations. Our proven quality and trusted partnerships make us the preferred choice for pharma innovators worldwide.
End-to-End CDMO Solutions
From route scouting to GMP manufacturing, we cover every stage of drug development.
State-of-the-Art R&D
Advanced laboratories for formulation, biologics, and peptide research.
Global Quality Standards
GMP-compliant facilities ensuring regulatory-ready production.
Advanced Manufacturing Capabilities
High-potent APIs, continuous flow chemistry, and scalable processes.
Sustainable & Compliant Operations
Environmentally responsible practices with stringent safety protocols.
Trusted by Pharma Innovators
Reliable partnerships delivering complex projects on time and within budget.
CMO Contract Manufacturing Organization India to USA
As a trusted Contract Manufacturing Organization (CMO), Shilpa Pharma delivers precision-driven, compliant, and scalable commercial manufacturing from India for US pharmaceutical companies. Our state-of-the-art manufacturing facilities are designed to support everything from small-batch production to large-scale commercial manufacturing, ensuring consistent quality, regulatory adherence, and dependable global supply.
We specialize in the manufacturing of complex APIs, high-potency compounds, specialty therapeutics, and advanced pharmaceutical products, executed under strict US FDA, cGMP, CDSCO, and global regulatory protocols. Every manufacturing program is managed with full transparency, robust documentation, and stringent quality controls, meeting the expectations of the US pharmaceutical and biotech market.
Manufacturing Strengths
- Precision & Compliance: Manufacturing systems aligned with US FDA, cGMP, CDSCO, and ICH guidelinesÂ
- Advanced Infrastructure: Facilities engineered for complex, high-potency, and high-value pharmaceutical productsÂ
- End-to-End Production: Seamless execution from technology transfer and scale-up to long-term commercial supply
CONTRACT DEVELOPMENT
Questions & Answers
Our FAQ's
What CDMO services does Shilpa Pharma provide for US pharmaceutical companies?
Shilpa Pharma offers end-to-end CDMO services, including contract development, API and formulation manufacturing, analytical support, scale-up, and commercial production aligned with US FDA, cGMP, and global regulatory standards.
Is Shilpa Pharma compliant with US FDA requirements?
Yes. Shilpa Pharma’s manufacturing facilities are US FDA inspected and compliant, operating under cGMP guidelines and supported by CDSCO-regulated manufacturing systems and global quality standards.
Why should US pharma companies partner with a CDMO in India?
Partnering with an India-based CDMO offers cost efficiency, scalable capacity, scientific expertise, and strong regulatory compliance, enabling US companies to accelerate development and reduce operational costs without compromising quality.
Can Shilpa Pharma manufacture high-potency APIs and complex molecules for the US market?
Does Shilpa Pharma support US regulatory submissions and DMF filings?
Our development and manufacturing programs generate regulatory-ready documentation, analytical data, and compliance packages that support US DMF submissions and FDA regulatory filings.
How does Shilpa Pharma ensure supply reliability for US partners?
We ensure supply reliability through robust quality management systems, transparent operations, validated processes, and dependable production scheduling, ensuring consistent on-time delivery for US customers.
Which therapeutic areas does Shilpa Pharma support for US CDMO services?
Are Shilpa Pharma’s facilities compliant with global regulatory authorities?
Yes. In addition to US FDA, our facilities comply with WHO-GMP, EU GMP, PMDA (Japan), ANVISA (Brazil), COFEPRIS (Mexico), TGA (Australia), and KFDA (South Korea).
What advantages does outsourcing CDMO services to India offer US companies?
Key advantages include lower development and manufacturing costs, flexible capacity, regulatory expertise, faster timelines, and access to advanced manufacturing infrastructure.
How does Shilpa Pharma manage quality and compliance for US CDMO projects?
We maintain end-to-end traceability, validated systems, strict quality controls, and continuous regulatory oversight, ensuring compliance with US FDA, cGMP, CDSCO, and international standards.
Countries We Serve in
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
