R&D
We are known for our ability to take a deep dive into what we do and our emphasis on research driven approach. Our R&D capabilities are the result of the best in class research equipment wielded by the best of experts in pharmaceutical manufacturing—science, stringent research and validation. Research plays a key role in our manufacturing and is a distinguishing factor of the Shodhana approach.
The several patents we hold in APIs, is a testimony to our R&D discipline and it is the same spirit that enables us to approach pellet development and manufacturing more comprehensively, weighing in every factor.
- R&D that has supported a long line of products developed for the US, European, Australian, Japanese, Korean, Asia Pacific and LATAM markets; and continuing to make explorations.
- The wherewithal to scale up quickly and efficiently, from lab to pilot to commercial levels.
- The ability to optimize, re-engineer and develop alternate processes, independently, and do it all in-house.
We enjoy the reputation of being the ‘go to’ manufacturer for many of the world’s most trusted brands. Focusing on molecules, we leverage this strong foundation—two decades of experience in manufacturing and meeting regulatory demands—to offer contract manufacturing of the highest standards.
For any formulation, the quality of raw materials that go into its manufacturing is paramount and as experts in manufacturing of APIs from intermediates, the control we have on the whole process, from start to finish, enables us to rise up to any challenge. Since every input is ours, we can trace back down the line, to make changes if need be. We are vertically integrated for a reason: zero dependency and full control on what we do. This is also why we are able to ensure strict adherence to global quality standards, and deliver on demand, as promised.
Manufacturing
Quality Management
Our pellets are used across the globe, in five continents. And quality is the cornerstone on which we build this global reach and business. Every stakeholder of ours, is aware of how crucial quality is at every stage of the manufacturing.
Quality Management Process manifests as a series of tests and checks throughout. Our quality management from start to finish includes checks, tests and validation throughout procurement, manufacturing, testing, storage and distribution. We continuously monitor, review and audit to improve and keep our Quality Management System dynamic.
- Certified facilities, utilities, machineries, materials, process and personnel.
- Comprehensive procedures and self-reviews.
- Training, internal auditing and preventive measures for continuous system development.
- Quality Management system for Change Control, CAPA, Deviations & Complaints [QMS].
- Qualified and auditable computerized systems to control the product process and quality.
Our experts are people who make it possible with their regulatory experience to develop and manufacture for products that reach out to over 50 countries. Meeting several regulatory requirements and manufacturing for different markets, we are today a repository of expertise on regulatory requirements, cGMP standards, DMF preparations, filing DMFs and systems development and implementation.
- 80+ DMFS, GLOBALLY, FOR A VARIETY OF PRODUCTS
- KFDA, TGA, COFEPRIS REGULATORY APPROVALS
- Many from our leadership team have several patents to their credit.
- Multiple Indian and US patent applications
USDMF FILED | ACCREDITATION OF FOREIGN MANUFACTURER BY PMDA, JAPAN | EU WRITTEN CONFIRMATIONS
We keep abreast of global regulatory framework, essential for organizing data generation as per submission norms mandated in respective territories.