The key element in generic drug development is the need for speed. There is a growing need to reduce the time in which a cheaper generic alternative is provided to the masses, staying within the regulatory framework and honoring the IP imperatives. We have as many as 200 scientists working on process innovation and simplification, manufacturing cycle time reduction, waste and energy reduction and continuous process improvement.
'Rachna', is a project management approach that drives our product development process. This approach ensures a smooth workflow from product selection, developing the synthesis route in R&D lab(s), plant scale-up and validations - finally culminating in the filing of a Drug Master File.
The focus is on using the most advanced techniques in product identification and structure elucidation. Our scientists have enabled us to develop processes for over 100 molecules. Their talent and superior R&D skills have fuelled rapid process development and reduction in product development time.
Expertise in multi-step synthesis.
Proven capability of technology transfer from Lab - Pilot - Commercial.
Development of innovative, cost-effective and environment-friendly processes.
Specialization in Impurity Profiling: Isolation, Identification and Characterization.
Central Process Engineering Laboratory (CEPL) set up to develop and implement techniques of Polymorphism and Crystallization.
Implementation of project management concept to ensure “Speed To Market”.
Selected by US Pharmacopoeia as one of their labs for analyzing and developing monographs.
Dr. Reddy's is committed to the manufacture of premium quality products in compliance with all regulatory requirements and customer expectations. We operate in accordance with cGMP requirements and the USFDA and ICH guidelines & regulations. All our manufacturing facilities are successfully inspected for several products by the USFDA and various other Agencies.
We are aided by a Best-in-Class Regulatory Affairs Team and we support our customers with DMFs for their dosage form approvals / ANDA filings. We have filed several DMFs in US, Canada (PMFs), Europe, Turkey, Korea, CIS and many more in other parts of the world. Some of our products have also recieved the Certificate of Suitability (COS) from European Pharmacopoeia
Our Customer support on Technical and Regulatory queries with constant focus on responsiveness, reliability, customization, and confidentiality set us apart from others. Continuous adaptation to the latest developments in global regulatory procedures and active partnership with Pharmacopoeial bodies give us cutting edge in this area.
