partner receives approval for a
key ANDA from the USFDA
Establishment Inspection
Report from USFDA for
Drug Product Manufacturing
offering one-stop
solution for biologics
and vaccines
manufacturing capacities
Stelis Biopharma's two biologics
manufacturing facilities receive
EU-GMP accreditation
Stelis Biopharma is a powerhouse to progress your biologics product to market as efficiently as possible, supporting the entire product lifecycle, for both drug substances and drug products. We are amongst the highest CDMO capacities in the APAC region.
Explore our
best-in-class facilities
Steils: Your Trusted Biopharma CDMO Partner
Mammalian and Microbial: MSAT, end-to-end PD and small-scale cGMP clinical and commercial manufacturing supported with drug product and quality control infrastructure.
Mammalian and Microbial: MSAT, cGMP clinical and commercial manufacturing supported with drug product and quality control infrastructure for all sterile formats.
Quality at Stelis
Quality is an integral part of everything we do at Stelis.
We reliably develop and manufacture products that meet our clients’ expectations and adhere to the highest worldwide regulatory standards.
Our experienced quality and regulatory personnel help us meet the highest global quality standards, ensure compliance and guide our clients through the regulatory approval. Our large-scale commercial use facilities were designed with consultation from international regulatory agencies, including the USFDA, and a holistic and systematic approach to building and sustaining the Stelis Quality Culture.
Why choose Stelis to be your CDMO partner?
Collaborative
We work side-by-side with our clients as true partners, collaborating and closely communicating every step of the way.
Agile
We have the proven ability to rapidly adjust or expand to meet the evolving needs and demands of our clients.
Compliant
We have established and will sustain a Stelis Quality Culture that enables us to always meet global quality and regulatory standards.
Trusted by top Biopharmaceutical clients globally
Stelis provides an inclusive and productive work culture where different perspectives are respected and valued. Our organization has provided me with avenues to develop and realize my true potential through assignments that challenged me to think out-of-the box.
Sujay BV
Stelis is an organization where one can explore novel approaches to overcome challenges. Working at Stelis is a lifetime opportunity where I can apply all my skills to develop and improve processes, and achieve business goals.
Vidyasagar Kannan
Everyone at Stelis demonstrates a growth-centric mindset. I am personally excited about our journey on vaccine development and commercialization. I am fortunate to work with an organization that is continuously striving to provide affordable drugs for public health with high emphasis on safety & quality.
Sripriya Kamath
Collaboration and transparent communication are the two main qualities that I learned at Stelis. For me, Stelis means agility for we can consistently deliver on the changing needs of the biopharmaceutical market.
Vibin Paul Varghese
I started my career as a Trainee and rapidly grew to the level of managing a brownfield project for the organization. Stelis has constantly challenged me to learn and develop through stretch assignments and supported me in my technical and leadership development.
Krishna Prasad P
I joined Stelis with strong research experience but with no exposure to the industry. Stelis has invested in my development to convert my research skills to fulfilling roles in analytical research, product development, quality assurance, managing CoEs for NCE filings, etc.
Abhinav Garg
Insights
Our Regulatory Approvals and Filings *
* Expecting audits and regulatory approvals during CY-22.