Artigo

An Outline of Dr. Reddy’s Peptide API Capabilities and Services

We have identified complex generics as a key focus area, and are embarking upon developing and commercialization of niche, difficult-to-make molecules involving complex chemistry. Peptide chemistry is one such area involving complex chemistry, purification, characterization, and regulatory pathway. We have complete peptide therapeutics development capability with state-of-the-art process facilities, supported by formulation optimization platform and cGMP quality system. We have proven capabilities in synthesizing complex peptides employing solid-phase peptide synthesis. Our expertise includes downstream purification, isolation, impurity profiling, and physicochemical characterization.

We are well-positioned to support our peptide API customers with APIs and services for peptides with extensive peptide therapeutics development capabilities, state-of-the-art process facilities supported by formulation optimization platforms and cGMP manufacturing capabilities. Our dedicated scientists and product managers have a deep scientific acumen in understanding solid, solution, and hybrid peptide API synthesis governed by a quality by design approach.

With our experienced technical and cross-functional team, we can quickly scale up and synthesize various peptides ranging from a few grams to multi-kilogram levels with technical expertise, modelling and simulation techniques. As peptide API manufacturers, our portfolio of peptide API list currently includes Semaglutide, Liraglutide, Icatibant Acetate, Tirzepatide, Bivalirudin, Aviptadil, Lanreotide, Calcitonin, Abaloparatide with others under development.

Dr. Reddy's has developed and established a complete quality management system to ensure the conformity of peptide products and to maintain the underline standard operation processes, including raw material controls, synthesis, purification, quality control, packaging, shipping, and customer complaints. In addition, we have strategic approaches in place to synthesize complex peptide API manufacturing.

We have complete peptide API therapeutics development capability with state-of-the-art process facilities, supported by formulation optimization platform and cGMP quality system. Our expertise includes downstream purification, isolation, impurity profiling, and physicochemical characterization. We also have in-depth scientific knowledge of solid, solution, and hybrid technology. In addition, we have access to unnatural amino acid building blocks via asymmetric hydrogenation/biocatalysis.

Our scientists and dedicated product managers leverage the expertise in complex organic chemistry combined with versatile capabilities and scales for production. Dr. Reddy’s development of new peptide APIs creates continuous innovation and knowledge expansion in chemistries and technologies. This innovation results from internal research projects and collaboration with external research institutions – all of which helps to improve processes with new peptide engineering and manufacturing solutions.

All our peptide API manufacturing processes comply with cGMP regulations as required by the FDA. We ensure the highest quality manufacturing process, a proven regulatory track record including DMF/CMC section for customers, IND and NDA filing, and deep experience with regulatory authorities such as the USFDA and EMA. Dr. Reddy’s provides comprehensive services on custom peptide synthesis for your peptide-based research and business. Our goal is to provide top-class services in cost, quality, and delivery time to our customers.

Want to know more about our peptide API capabilities? Then please write to us at api@drreddys.com.