Sameer Goel

Managing Director

The pharmaceutical CDMO market is rapidly evolving with outsourcing accelerating globally. Most compa­nies aim to cut costs, speed up time-to-market and ac­cess expertise in high-potency APIs, biologics and advanced processing. In India, this momentum is even stronger, driv­en by the “China+1” strategy.

Supportive government pol­icies, such as Bulk Drug Parks and PLI schemes along with a skilled workforce are further reinforcing this growth. To­gether, these factors are positioning the country as a hub for complex drug substances, biosimilars and integrated CDMO services.

However, challenges persist, including cost erosion in generics, raw material volatility and stricter regulatory scrutiny, alongside the demand for rapid, compliant tech transfers. Amidst this challenging landscape, Kimia Biosciences addresses these aforementioned issues with proven process development, 220 kL cGMP capable-capacity, and robust QA/RA and IP systems, ensuring efficient, audit-ready and scalable solutions.

A Noteworthy Journey

Kimia Biosciences' growth journey has been multi-dimensional, wherein, it has progressively expanded its R&D team and manufacturing infrastructure. Additionally, the company has strengthened its scientific workforce and diversified its product portfolio to include cardiometabolic, respiratory, CNS, urology and anti-infective APIs. Furthermore, Kimia Biosciences' strategic presence across both Indian and global markets underscores the deepening of partnerships and the expansion of its footprint worldwide.

Kimia Biosciences differentiates itself by providing truly end-to-end pharmaceutical manufacturing solutions, spanning from early development to final delivery. Its DSIR-approved R&D center in Gurugram, complemented by an additional facility in Hyderabad, is staffed with skilled scientists, engineers and analytical experts who manage process chemistry development, impurity profiling and tech transfer.

Once processes are optimized, they transition seamlessly into the company’s multi-product, cGMP manufacturing facilities. These facilities combine flexibility by handling solids through centrifuges, Nauta mixers, FBDs, VTDs, and advanced drying systems. These systems have a broad operational range, from ultra-low cryogenic chemistry to high-pressure executions.

Dedicated QA/QC labs, equipped with 21 CFR-compliant instrumentation and robust stability testing systems complete the cycle, ensuring every batch meets the stringent requirements for regulated market supply.

Additionally, the company is recognized in the market for its core services, which include the development and manufacturing of APIs, KSMs and intermediates such as analytical method development & validation and tech transfer support through to commercial scale. The company is also steadily expanding into CRAMS and CDMO-CRO services.

Carving a Niche for Itself

Its key differentiators lie in multidisciplinary expertise in complex, multi-step and chiral chemistry, alongside the integration of advanced techniques such as design of experiments (DoE), QbD principles, micro-channel reactors, enzymatic synthesis and green chemistry. Kimia Biosciences also offers strong IP evaluation capabilities to ensure processes are efficient and non-infringing.

Complementing this is a rigorous QA/QC culture, built on WHO-GMP and ISO compliance, which helps partners remain audit-ready across global markets.

Global pharmaceutical clients partnering with the company gains several distinct advantages. On speed, the company’s integrated R&D and manufacturing teams accelerate the entire lifecycle from discovery to delivery, with extensive experience ensuring smooth tech transfers.

On scale, Kimia Biosciences offers a comprehensive range of reactor capacities and materials-handling systems that support flexible and rapid scale-up. Finally, supply resilience is strengthened through backward integration into KSMs and APIs, reducing geographic sourcing risks in volatile supply chains.

Facilitating Complete Support

Kimia Biosciences provides comprehensive support across the entire product lifecycle, beginning with route scouting, salt & polymorph screening, method validation. The company also extends through stability studies, validation batches, post-approval changes and regulatory DMF preparation. This continuum is backed by a team of highly qualified chemists, engineers and analysts, supported by dedicated QA, regulatory and IP experts. "Every decision we make is scientifically sound, commercially viable and fully compliant, whether in preclinical development or commercial supply", states Sameer Goel, Managing Director, Kimia Biosciences.

R&D Capabilities

Kimia Biosciences' R&D capabilities are anchored in its DSIR-approved centers, where advanced technologies such as DoE/QbD, continuous processing, flow reactors, enzymatic steps and green chemistry are actively deployed. Combined with expertise in impurity science, analytical validation and ICH-aligned stability programs, it enables accelerated product development while ensuring scalable, cost-efficient and differentiated outcomes for clients. The R&D team of over 60 scientists has already commercialized more than 30 molecules, with 9–10 additional molecules in the near-term pipeline and multiple patent filings in progress.

Global Regulatory Compliance

Operating in a highly regulated industry, the company ensures global compliance by embedding rigorous quality systems into its processes, including change control, CAPA, APR, stringent vendor qualification, training and self-inspection.

Its laboratories and data systems are fully compliant with 21 CFR Part 11 requirements, while method validation and stability testing are conducted in line with ICH guidelines. Backed by WHO-GMP and ISO certifications, this layered and proactive compliance framework keeps the company audit-ready. This enables the company to confidently support clients across diverse regulatory regimes.

A Robust Future Roadmap

Kimia Biosciences is actively expanding into CRAMS, CDMO-CRO and FDF services to complement its core API and KSM offerings. Its development portfolio is also widening to include critical raw materials and proprietary APIs, enhancing both cost-efficiency and supply autonomy. Additionally, the company is investing in next-generation R&D capabilities to meet the evolving demands of global clients who require innovation alongside strict compliance.