Global CDMO Excellence
Shilpa Pharma accelerates innovation with end-to-end CDMO expertise in small molecules, peptides, HPAPIs, ADC linkers, polymers, and specialty chemicals—delivering speed, quality, and global reach.
Why Shilpa Pharma Lifesciences
At Shilpa Pharma Lifesciences, we are a trusted end-to-end CDMO partner, seamlessly guiding projects from development to commercial-scale manufacturing with a focus on speed, quality, and compliance.
- Comprehensive Expertise: Small molecules, peptides, HPAPIs, ADC linkers, specialty chemicals, polymers, and advanced analytical services.
- Regulatory Excellence: Proven track record with zero-observation USFDA audits and consistent global client satisfaction.
- Integrated Solutions: IP protection, regulatory support, and customer-centric collaboration tailored to your molecule’s journey and a strong track record of client success.
- Sustainability Commitment: Beyond technical strength, sustainability is at the heart of our growth. By aligning with UNGC, SDGs, PSCI, NDC, and the SBTi initiative, we create long-term environmental and social impact while driving global healthcare forward.
Specialized Products for Advanced Therapies
Your trusted one-stop partner for high-quality pharmaceutical ingredients, driven by science, regulatory excellence, and customer trust. With expertise in complex molecules and advanced technologies, we deliver reliable pharma solutions that power the future of innovative and life-saving therapies.
Developing ADCs and PDCs with advanced precision, ensuring targeted therapies, safety, and efficacy.
High-quality PEG derivatives supporting bioconjugation, solubility, and innovative drug development.
Expert synthesis of therapeutic peptides with high purity, stability, and innovation, supporting research, clinical development, and global healthcare.
Manufacturing specialty chemicals with precision, sustainability, and compliance, tailored to pharmaceutical, biotech, and industrial applications worldwide.
Have Questions? We’re Here to Help
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
Shilpa Pharma Globally Accredited, Widely Trusted
Recognized with prestigious regulatory approvals and accreditations, Shilpa Pharma is the partner of choice for leading distributors and healthcare innovators worldwide. Our proven compliance, quality excellence, and customer trust drive stronger collaborations across global markets.
Our World-Class Infrastructure
Experience Shilpa Pharma state-of-the-art manufacturing and R&D facilities, designed to deliver innovation, compliance, and scalability. From advanced laboratories to global-standard production sites, our infrastructure powers the seamless journey of molecules from development to commercialization.
Why Choose Shilpa Pharma for CDMO Services
Partnering with Shilpa Pharma means choosing reliability, innovation, and uncompromising quality. With end-to-end expertise, regulatory excellence, and customer-centric collaboration, we deliver more than products – we create long-term value and sustainable growth for your business.
End-to-End CDMO Expertise
Comprehensive solutions across every stage of the drug development cycle.
Customer-First Approach
Dedicated to building lasting partnerships with tailored solutions.
IP & Data Integrity Assurance
Ensuring the highest standards of intellectual property protection and data security
Cost-Optimized Solutions
Delivering value-driven services without compromising quality or compliance.
Speed-to- Market Advantage
Agile execution that helps accelerate your product’s journey to market.
Proven Reliability
Over three decades of trusted experience in the pharmaceutical industry.
Our Case Studies
Ph2 API RSM Development
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus
Add Your Heading Text Here
Quality Care You Can Trust
Our Client Testimonials
Questions & Answers
Frequently Asked Questions
Everything You Need to Know About Shilpa Pharma
What makes Shilpa Pharma different from other pharmaceutical companies?
Shilpa Pharma stands out with its focus on innovation, global regulatory approvals, world-class infrastructure, and a strong commitment to quality, compliance, and affordability.
What types of pharmaceutical products does Shilpa Pharma manufacture?
We specialize in a wide range of formulations including oncology, generics, active pharmaceutical ingredients (APIs), and specialty drugs, catering to both domestic and international markets.
Which global markets does Shilpa Pharma serve?
Shilpa Pharma exports to regulated and emerging markets worldwide, with approvals from leading authorities such as USFDA, EMA, TGA, and more.
What quality certifications and accreditations does Shilpa Pharma hold?
Our facilities are accredited by global regulatory agencies and comply with stringent international standards, ensuring safety, efficacy, and trust in every product.
Does Shilpa Pharma provide contract manufacturing or partnerships?
Yes, we collaborate with global pharmaceutical companies through contract manufacturing, licensing partnerships, and research collaborations.
How does Shilpa Pharma ensure product quality and safety?
Every product undergoes rigorous testing, from R&D to final packaging, under strict quality assurance protocols aligned with global regulatory standards.
Can international distributors and healthcare companies partner with Shilpa Pharma?
Absolutely. We welcome global partnerships and collaborations to expand access to high-quality medicines across the world.
How can I get in touch with Shilpa Pharma for business inquiries?
You can reach us through our official website’s contact form or email our business development team directly for partnership and distribution opportunities.
What are oncology drugs, and why are they complex to manufacture?
Oncology drugs are medications used to treat cancer. They are complex because they often involve highly potent compounds, require specialized containment facilities, and strict regulatory oversight.
What quality checks are performed before medicines reach the market?
Each batch undergoes stability testing, clinical validations, laboratory analysis, and quality assurance audits to ensure it meets global safety and efficacy standards.
How long does it take to develop and manufacture a new drug?
Depending on complexity, it can take anywhere from 8 to 12 years, including research, clinical trials, and regulatory approvals.
What is the importance of technology in pharma manufacturing?
Advanced technologies like continuous manufacturing, AI in drug discovery, and automation help reduce errors, improve efficiency, and bring medicines to market faster.
Does outsourcing manufacturing affect product quality?
No. A reliable pharma manufacturer with global certifications ensures the same quality standards whether the product is developed in-house or through contract manufacturing.
Countries We Serve in
Learn About Shilpa Pharma Lifescience
Shilpa Pharma Lifesciences- What to Know
Shilpa Pharma Lifesciences Limited is a leading CDMO (Contract Development & Manufacturing Organization) and pharmaceutical company that provides end-to-end chemistry, development, and manufacturing solutions to clients across the globe.
It is a part of the Shilpa group (under Shilpa Medicare Limited) with decades of experience in the life sciences sector.
From early phase research through commercialization, Shilpa Pharma offers a wide range of services and products in APIs, linkers, payloads, specialty polymers, and more.
What Shilpa Pharma Lifesciences Includes (Capabilities & Offerings)
Shilpa Pharma’s capabilities span across multiple verticals of pharmaceutical development, manufacturing, and support services. Some key offerings are:
1. CDMO Services (Full Spectrum)
- Route Scouting, Process Research, and Development
- Scale-up and pilot-to-commercial campaigns
- Tech transfer, risk assessment, and regulatory support
- Preclinical, clinical, and commercial supply solutions
2. Product Offerings
- APIs (Active Pharmaceutical Ingredients), including oncology and non-oncology compounds
- Linkers, payloads, PEGs, specialty polymers and related advanced intermediates
3. Analytical & Quality Services
- Analytical method development & validation
- Impurity profiling, polymorph/solid-state studies
- Stability studies, method transfer, and regulatory documentation support
Shilpa Pharma - Strong Quality Management System, compliance with global regulatory standards (USFDA, EMA, PMDA, etc.)
4. Manufacturing Infrastructure
- Unit I (API manufacturing, both oncology and non-oncology)
— 6 manufacturing blocks (3 for oncology, 3 for non-oncology)
— Reactor capacities: ~38,000 L (non-oncology) and ~28,000 L (oncology)
— Approvals: USFDA, EUGMP, TGA, PMDA, KFDA etc.
Unit II (100% EOU API & R&D facility) - Additional formulation, biologics, and analytical units under the Shilpa group
5. Sustainability, ESG & CSR
- Environmental management (ISO 14001 etc.), safety, health systems
Shilpa Pharma - Social initiatives: education, rural development, health awareness, sports & youth support
Why Shilpa Pharma Lifesciences Is Among the Best
Here’s what makes Shilpa Pharma a compelling choice for partners and clients:
End-to-End, Integrated Capability
From concept to commercialization, they handle multiple steps in-house, reducing complexity and risk.Regulatory Approvals & Global Credibility
Their facilities hold approvals from stringent regulators (USFDA, EU GMP, TGA, PMDA, KFDA) for many units.Deep Expertise in Complex & Oncology Molecules
The focus on difficult chemistries, high‐potent APIs, biologics, linkers & payloads distinguishes them from more generic CDMOs.Strong R&D and Innovation Orientation
Over 35+ years’ experience, continuous investments in new modalities and differentiated product strategies.Scalable Capacities & Modern Infrastructure
Large reactor volumes, multiple blocks, ability to scale from gram to commercial scale.Customer-Centric & Reliable Execution
Emphasis on IP protection, data integrity, time-efficient execution and cost-effective solutions.Sustainability & Ethical Governance
Commitment to ESG, environmental stewardship, community upliftment and responsible operations.Proven Track Record & Global Market Presence
Operating across 50+ countries, with significant regulatory filings and partnerships globally.
Global Regulatory Approvals and Compliance
As a globally recognized API supplier in India, Shilpa’s manufacturing facilities meet the highest international quality standards. The company holds approvals and certifications from several major regulatory bodies, ensuring consistent product quality and regulatory compliance.
Our facilities are:
- USFDA Approved (United States Food & Drug Administration)
- EU GMP Certified (European Union Good Manufacturing Practice)
- ANVISA Approved (Brazilian Health Regulatory Agency)
- COFEPRIS Approved (Mexico)
- TGA Certified (Australia)
- PMDA Approved (Japan)
- KFDA Certified (South Korea)
These certifications position Shilpa Pharma as a trusted partner for both regulated and semi-regulated markets.