At Ceyone Life Sciences, our Bulk Drug Manufacturing capabilities are built on seamless integration of R&D depth, process innovation, and commercial-scale execution—delivering high-quality APIs and intermediates with speed, precision, and compliance.
- Seamless Lab-to-Commercial Scale Manufacturing
- Rapidly transition molecules from lab to commercial scale
- Minimize risks associated with scale-up
- Customized project
- Comprehensive API & Intermediate Capabilities
- Active Pharmaceutical Ingredients (APIs) for therapeutic applications
- Key Starting Materials (KSMs)
- Regulatory Starting Materials (RSMs)
- High-value Intermediates and Specialty Chemicals
- Process Development & Optimization
- Design of Experiments (DoE)
- In-line Process Analytical Technology (PAT)
- Right-First-Time (RFT) execution
- World-Class Infrastructure & Regulatory Compliance
- GMP-compliant manufacturing blocks
- Versatile reactor capabilities (cryogenic to high-temperature)
- Dedicated areas for potent and sensitive molecules
- Advanced instrumentation (HPLC, LC-MS, GC-MS, NMR, etc.)
- End-to-End Support for Clients
- Process Validation & Technology Transfer
- Stability Studies & Analytical Validation
- Regulatory Filing Support (DMFs, IND, CMC documentation)
- Quality Assurance & Project Management
- Supply Chain Management ensuring consistent and timely delivery
Why Choose Ceyone for Bulk API Manufacturing?
Scalable Capabilities
From pilot batches to full-fledged manufacturing, we support your pipeline at every stage.
Complex Process Expertise
Agile in handling high-potency APIs and advanced intermediates with precision and safety.
Regulatory Readiness
Structured support for DMF/CMC, IND filings, and global compliance.
Reliable Supply Assurance
Controlled, quality-driven output built for timely delivery and consistency.
Popular questions
What types of APIs and intermediates do you manufacture?
We specialize in niche APIs, high-value intermediates, and specialty chemicals, along with Key Starting Materials (KSMs) and Regulatory Starting Materials (RSMs). Our portfolio covers both commercially established molecules and custom synthesis for client-specific projects.
Do your facilities comply with global regulatory standards?
Yes. Our manufacturing units are designed to meet GMP standards and align with international regulatory requirements such as USFDA, EMA, WHO, and ANVISA. We also provide full regulatory documentation support including DMFs, INDs, and CMC filing.
Can you support both small-scale and commercial-scale production?
Absolutely. We offer end-to-end scalability—from lab-scale feasibility studies to pilot plant batches and commercial-scale manufacturing. This allows clients to work with a single partner throughout the drug development lifecycle.
How does Ceyone ensure quality and consistency in API manufacturing?
We follow a Quality by Design (QbD) approach, using advanced techniques like Design of Experiments (DoE) and Process Analytical Technology (PAT). Each process undergoes validation, stability testing, and analytical checks to ensure reproducibility, compliance, and safety.
Do you provide contract manufacturing services?
Yes. We act as a trusted contract manufacturing partner for global pharma and chemical companies, providing flexible, cost-effective solutions with complete confidentiality and IP protection.
What industries do you serve besides pharmaceuticals?
In addition to pharmaceuticals, we also support industries such as agrochemicals, flavors & fragrances, polymers, dyes, surfactants, and specialty materials, leveraging our expertise in custom synthesis and specialty chemicals.
How can we collaborate with Ceyone Life Sciences?
You can connect with our team to discuss your requirements for APIs, intermediates, or specialty chemicals. We’ll evaluate your needs and provide a customized manufacturing solution aligned with your timelines, budgets, and regulatory expectations.