Shilpa Pharma Lifesciences
Our Promise to You
Quality at the Core
Quality is not just a goal; it’s a journey that we embark on every day. Our story begins with a commitment to maintaining robust quality systems across all our facilities, ensuring that we consistently meet high standards, no matter where we operate.
Sustainability
At Shilpa Pharma Lifesciences, sustainability is a core business principle, ensuring that our operations align with global environmental and social responsibility standards. We are abiding by the principles set by some of the global forums including UN Global Compact (UNGC), SDGs, PSCI and NDC and have endorsed commitments to Science-Based Targets Initiative (SBTi), reinforcing our long-term sustainability goals.
Quick facts
Leading the way with us!
1987
Established
100+
R&D workforce
1500+
Team size
3
Manufacturing site
100+
Audits
500+
Customers
100+
Projects
Why partner with us?
At Shilpa Pharma, we take pride in being a trusted and preferred CDMO partner for pharmaceutical and biotechnology companies worldwide.
Full CDMO Spectrum
Shilpa Pharma offers a full CDMO spectrum, covering every stage of the drug development cycle.
Customer-Centric Approach
At Shilpa Pharma, our dedication to our customers influences every facet of our operations.
IP Protection and Data Integrity
Recognizing the vital importance of IP and data integrity in pharmaceutical Industry
Cost-Effective Solutions
We provide cost-effective solutions without compromising on quality, safety, or compliance.
Time-Efficient Execution
At Shilpa Pharma Lifesciences, we understand the critical importance of speed-to-market in the competitive edge industry
Reliable Partner
With over more than three decades of experience in the pharmaceutical industry
Testimonial
Success Stories from Our Clients
Testimonial
Success Stories from Our Clients
Let's connect
Get in touch to discuss how our expertise in pharmaceutical development and manufacturing can help bring your innovations to life with quality and precision
Related resources
Case studies
Route scouting, Process Development and Supply of Sterol API
Process Development and Supply of Clinical API
Reactor Customization & Process Development using Flow Technology
Route scouting, Process Development and Supply of Sterol API
Process Development and Supply of Clinical API
Reactor Customization & Process Development using Flow Technology
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.
Shilpa Pharma’s extensive oncology experience was instrumental in our IND submission. Their support in producing toxicology batches for our solid tumor studies, along with their precision and high quality regulatory documentation, played a key role in our success.
Oncology focused NASDAQ Listed Biotech, United States