The One Stop Shop to your Needs!

Dr. Reddy’s Custom Pharmaceutical Services is an emerging leader in Contract Manufacturing and Development for Innovators worldwide.

At CPS we understand that innovators face the challenge of developing the optimum process for manufacture of their NCE in shortest possible time and therefore getting the molecule into clinical trials as soon as possible is of paramount importance. The complex chemistry behind the scale up processes is also very well understood and we know what it takes to get your NCE to the shelf. That is why we offer end-to-end solution to your needs – be it process development, analytical development, formulations development or cGMP manufacture of API as well as Contract Manufacturing Dosage.

Working as a pharmaceutical company for the last 2 decades we have acquired expertise in specialized technologies with synthetic ability including Stereoselective / Regioselective synthesis, Chemical resolution of racemates, Aminoacid chemistry, azide chemistry, biotransformations, organomteallic and metal hydride reactions and also industrial chromatography. Being able to fully appreciate the speed and skills required in process development in delivering suitable (Gram to Kilos to Tons) quantities of APIs and Intermediates, as the NCE moves from clinical studies to commercialization, we already have state-of-the-art and well equipped dedicated 21 Process R&D labs and 7 Analytical R&D labs. Our Kilo Lab and the plant plat has 25 to 250 L reactors (stainless steel and glass lined), is equipped for wide range of temperature capabilities (-800C to 3000C), has a dry reaction assembly and a class 100,000 clean room. Our cytotoxic facility is equipped with class 100,000 suite and 20L and 50L reactors. Our Process Research and Development Labs carry the competence in process research to develop novel and non-infringing processes, and it is complimented by the extensive experience in polymorphic studies. If your need be related to chiral molecules, we have significant expertise in that as well.On bulk manufacturing side, our strength of seven high performance multi-ton API production facilities built and operated as per cGMP norm also includes six pilot plants and more than 3 million liters reaction volume. These API production sites include over 600 reactors ranging from 25L to 20KL. In case you are wondering, yes, all our sites are inspected by USFDA and we haven’t received any 483s in the last 4years. Apart from USFDA, we are also inspected and approved by MCA, MCC and TGA.

Being a proactive organization and with a mindset to continually enhance our portfolio of offerings to our customers, a former Roche / Syntex facility in Mexico was acquired by Dr. Reddy’s in December 2005 and this has given us an expertise much needed for catering to the customer’s steroidal API development as well as manufacture needs. While this site is also FDA approved, it has 3350 MT installed capacity with proven technical capabilities. Our Mexico steroid manufacturing facility has capabilities in complex chemical synthesis as well as cryogenic reactions.

No chemistry is complete without sound Analytical Research and Development capabilities. And that is why our strength in Analytical R&D includes method development and validation, characterization and structure elucidation of New Chemical Entities, Intermediates and Active Ingredients. We carry out compendia testing (USP, BP, JP and EP); isolation, identification and synthesis of impurities with the aid of latest equipments such as NMR (200 / 400 / 500 MHz), GC-LC-MS, LC-MS-MS, LC-NMR, single crystal and powder X-Ray diffractometers.

We understand the need of customers to get the entire project – from process development to scale up to dosage development and finally contract manufacturing dosage – done at one point source. And quite truly with out mentioning the finished dosage capabilities the picture would not be complete. For formulation development we have capabilities in Modular Production Process as well as Tablets and Capsules (hard / soft gelatin) manufacturing. And our formulations sites are also US FDA, MCA, MCC and TGA inspected.

While we went about building this might it is worth mentioning that we never lost track of customer focus all this while. We went ahead and captured details of each and every project so that we can grow in a direction where the Customer is confident of working with us. And we have thus tried to build a facility that can truly offer all the solutions that any innovator or even a big pharma may need. By integrating most of the Custom Manufacturing Services we have attempted to avoid the costs involved in technology transfers and needless to say the reduction that this has brought about in time for completion of any project.

Every project execution is done with a unique project manager being assigned to that project. The Project Mode is achieved with a kick off meet amongst the team members and the deliverables are clearly understood by every stakeholder. In the project mode we believe that maximum productivity can only be achieved through open and transparent communication with the customer. And this is accomplished by, providing fortnightly reports to our customers together with regular updates via telecons.

It is said strength without responsibility is of little value to anyone. And Dr. Reddy’s understands this well. That is why at all our facilities environmental concern is focused on zero impact. We deploy most modern effluent treatment techniques leading to ‘Zero Liquid Discharge (ZLD)’ status in all our plants. Even in our plants we apply the same fundamental thinking governing our quest to support our innovator partners – process optimization to maximize yield and minimize effluents. Solvent recovery and steam stripping for reduction of odorous emissions is also applied to the effluents. And in the end we get no waste at all since the solids left afterwards are also incinerated. It is a responsibility that we owe to the environment and we understand it well.

Being the youngest member of Dr. Reddy’s we have already proved our mettle to our stakeholders as well our customers and have built a customer base that has a steadily growing number of repeat orders. So, why wait? Come partner with us and see your dream NCE quickly and effectively enter the army of medicines that is trying to do its bit to make this world a better place.
Dr. Reddy’s Custom Pharmaceutical Services – One Partnership, Many benefits!