Dr. Reddy's Laboratories SA

Dr. Reddy's Custom Pharma Services manufactures outsourced pharmaceutical products in a broad range of dosage forms. Our strategy for success is based on adherence to three principles: outstanding quality; international regulatory compliance; and superior technology transfer capabilities. With ten formulation facilities including an R&D and pilot plant centre, we ensure supply security for different dosage forms across a broad range of therapeutic areas. High-quality standards in accordance with international regulatory standards make us the preferred commercial manufacturing partner for the world’s top pharmaceutical companies.

Highly potent dosage forms and oncology products

To support the rapidly growing HPAPIs and oncology drug market, Dr Reddy's has a dedicated state-of-the-art high potency dosage manufacturing facility for clinical trials and commercial manufacture. The GMP facilities are designed to manage high containment processes for clinical trial material, registration batches and commercial supplies of the following dosage forms:

• Tablets
• Capsules
• Liquid Injectables
• Lyophilized powder for injection

Creating high-quality, affordable active pharmaceutical ingredients (APIs) is one of the keys to help us bring good health to all. Our API Business caters to leading innovator and generic companies across the US, Europe, Latin America, Japan, Korea and other emerging markets. Over the years, we have developed deep technical strengths in the development of complex APIs such as steroids, peptides, complex long chain synthesis and oncology. Our expertise in intellectual property and regulatory issues helps us consistently deliver the highest quality APIs that meet or exceed regulatory standards. At the same time, our agility enables our customers be the first-to-market by providing offerings ranging from intermediates to end formulations.

CPS is one of the leading manufacturers and suppliers of GMP grade Activated mPEGs for the conjugation of proteins, antibody fragments and peptides to improve the stability and pharmo-kinetic properties of biologic drugs. With outstanding GMP capabilities and back integration to high purity mPEG-OH we can guarantee the quality, consistency and security of supply of our Activated mPEG products. Our product range has the following characteristics:

• Varied activating groups including Maleimide, pNP-carbonate, propionaldehyde, Amine, NHS ester, iodoacetemide, thiol etc.
• Full range of molecular weights; from 2 to 40 kDa
• Excellent levels of activation
• Low Diol content
• cGMP manufacture from lab to commercial scale
• Custom Activation

Our customers range from large pharmaceutical to small biotech companies involved in the development of biologic drugs. CPS is able to provide a scale up and cGMP manufacturing service second to none, which enables our customers to progress their candidates through the clinical trial process and on to commercialization with complete confidence.

Early route selection and innovation is undertaken at our R&D facility in Cambridge. Development of meaningful analytical methods provides customers with the critical information about the Activated mPEG that they need. Manufacture and analysis are transferred to our Mirfield site for further scale up, development and optimization for the critical manufacture of GMP products used in clinical trials. The site has extensive experience in supply of GMP Activated mPEGs for all phases of clinical development and commercial supply and has the facilities and capabilities necessary for the full range of volume requirements.

We help to accelerate the time-to-market of your peptide APIs and formulations

Dr. Reddy’s peptide unit has decades of experience in process development and production of peptide APIs and formulations. This experience is brought to bear on a comprehensive offering that integrates a continuum of services for custom peptide synthesis including:

• route design
• feasibility studies
• process development
• process optimization and validation
• commercial manufacturing
• regulatory and marketing support

Our scientists and dedicated project managers leverage Dr. Reddy’s experience in complex organic chemistry combined with versatile capabilities and scales for production. Dr. Reddy’s development of new peptide generics creates continuous innovation and knowledge expansion in chemistries and technologies. This innovation is a result of internal research projects and collaboration with external research institutions – all of which helps to improve processes with new peptide engineering and manufacturing solutions (e.g. continuous solid-phase synthesis).

Peptide services seamlessly integrate with Dr. Reddy’s capabilities in activated mPEGs, special chiral building blocks including carbohydrates, and handling of highly potent APIs (HPAPIs) that can include non-amino acids, cyclization or conjugations. Our services include:

Solid-phase Peptide Synthesis
Longer peptides often require solid-phase synthesis using an Fmoc protection group strategy on an appropriate resin.  Dr. Reddy’s uses automated synthesizers and small-scale equipment for production of research-grade material and for toxicology studies. For production of material for small- and large-scale clinical trials, Dr. Reddy’s is equipped with solid-phase reactors with output up to multi kilo scale and corresponding cleavage systems. 

Liquid-phase Peptide Synthesis
Short- and medium-sized peptides often require a liquid-phase strategy in small- and large-scale equipment. Longer peptides can be produced by applying a fragment approach (Fmoc or BOC strategy) or using a combination of production of fragments on solid support and subsequent condensation of fragments in solution.  Oftentimes, this strategy reduces the number of purification steps providing material with very high purity and attractive economy.

Downstream Processing
Our labs are equipped with multiple HPLC units for the purification on reverse phase and in- process quality control. The large-scale formulation facilities offer fill and finish solution up to 100 kg.

Analytical Techniques
Dr. Reddy’s offers the following characterization of peptides: 

• LC and HR MS for mass and primary structures
• HPLC determination of assay and impurity profile
• characterization by NMR sequence analysis
• determination of heavy metals and counter ion
• characterization of enantiomeric purity
• determination of N-terminal
• secondary and tertiary structure and
• capillary-electrophoresis for mapping of poly saccharides

Quality and Regulatory Expertise
Dr. Reddy’s boasts the highest quality manufacturing, a strong regulatory track record including DMF/CMC section for customers, IND and NDA filing, and deep experience with regulatory authorities such as the US FDA and EMA.

Dr. Reddy’s Centre of Excellence for chiral technologies is located in the Chirotech Technology Centre in Cambridge, (UK). With over 20 years of experience using proprietary and non-proprietary chiral technologies to produce single enantiomer compounds, this world-class center is equipped with the infrastructure and staff to quickly develop a chiral solution that meets partner needs.

Chiral Technologies include:

Asymmetric Chemocatalysis
As a recognized world leader in Asymmetric Chemocatalysis, our work is realized through technical expertise and access to a diverse collection of proprietary, third-party, and IP-free ligands and catalysts. We offer experience in all areas of asymmetric chemocatalysis from catalyst screening to implementation of a process in production reactors.

Biocatalysis
The Biocatalysis group, a pillar of our chiral technology offering, uses proprietary and non-proprietary enzymes in partner projects. Our ability to discover an enabling enzyme for a transformation and to produce the enzyme in-house with an in-licensed proprietary expression system allows the development of a customized solution for the desired chiral product.

Diastereomeric Resolution
Diastereomeric Resolution, a classic approach to producing chiral compounds, provides a third option for our partners and completes our formidable chiral technology offering. Rather than force-fitting a single technology to a partner’s project, we strive to offer a chiral solution by using the most appropriate tool in our many-faceted chiral toolbox. Furthermore, we are experts in the marriage of an enabling chiral step to traditional chemical development - thus fostering the establishment of the best overall scale-up route. We welcome the opportunity to discuss our flexible and collaborative approach to R&D programs, which facilitate the commercial-scale supply of RSMs, Intermediates and APIs.

Dr. Reddy's Custom Pharma Service offers a complete solution for highly potent and cytotoxic compounds from API development and manufacturing to development and commercial manufacturing of the finished product.

We can support you with an exceptional breadth of capabilities for development and manufacture of nearly all classes of highly potent compounds. This breadth of capabilities covers classes of compounds, scale of operation, unit operations and geography of facilities. Within the class of cytotoxic products we have multiple high potency suites at our facilities in India. These include kilolab and various scales of commercial manufacturing with vessels up to 2500 liters. Containment is per most modern technologies, meeting limits of 0.2 μg/m³ over an 8 h exposure. We have 10 modules of varying size, each located within USFDA inspected manufacturing facilities and supplying products to all major markets worldwide. We also have the required laboratory experience and facility to develop processes for developmental APIs. Our FTO-7 site at Vizag in India is a state-of-the-art manufacturing facility for oncology products.

High quality APIs to accelerate your generic product launches. Catering to leading innovator and generic companies across the world, Dr. Reddy’s is recognized as one of the largest API suppliers worldwide. The launch of Dr. Reddy’s XCEED – a digital customer service platform - gives customers instant access to an industry leading portfolio which spans across a wide range of indications and complex molecules such as steroids, peptides or highly potent, APIs (HPAPI). Customers across the globe are able to manage the whole business process in real time, from ordering samples to submit and track their orders, but also to closely interact with Dr. Reddy’s interdisciplinary support team and much more. For more information, log on to: api.drreddys.com

Dr. Reddy's Laboratories Ltd. offers a wide range of products which includes Differentiated Formulations. This products division focuses on initiatives to improve patient experience with our products. Better experience results in better compliance, which means better health and outcomes for patients. Contact us for more information.

Dr. Reddy’s has the capabilities and capacities to manufacture and deliver Telmisartan in accordance with global regulations. Our team of experts developed processes and the analytical methods to avoid the presence of nitrosamine impurities, which are already suitable to confirm future requirements of the EMA (NDEA or NDMA limits of <0.03 ppm). 

Dr. Reddy’s has the capabilities and capacities to manufacture and deliver Irbesartan APIs in accordance with global regulations. Our team of experts developed processes and the analytical methods to avoid the presence of nitrosamine impurities, which are already suitable to confirm future requirements of the EMA (NDEA or NDMA limits of <0.03 ppm). 

Dr. Reddy’s has the capabilities and capacities to manufacture and deliver sartan APIs in accordance with global regulations. Our team of experts developed processes and the analytical methods to avoid the presence of nitrosamine impurities, which are already suitable to confirm future requirements of the EMA (NDEA or NDMA limits of <0.03 ppm). 

Dr. Reddy’s has the capabilities and capacities to manufacture and deliver sartan APIs in accordance with global regulations. Our team of experts developed processes and the analytical methods to avoid the presence of nitrosamine impurities, which are already suitable to confirm future requirements of the EMA (NDEA or NDMA limits of <0.03 ppm). 

What are APIs? As the name suggests, Active Pharmaceutical Ingredients (APIs) are the heart of any dosage form, whether they are oral, injectable or inhaled, and are absolutely essential to the development of a formulated product.

At Dr. Reddy’s, we’re in the business of ensuring good health for both people and the planet. Our experts will share insights on our sustainability approach and on how it helps B2B customers support their sustainable supply chain performance while sourcing APIs. Please register here: 

Dr. Reddy's announced that it has entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. (Gilead) that will grant Dr. Reddy’s the right to register, manufacture and sell Gilead’s investigational drug, Remdesivir, a potential treatment for Covid-19, in 127 countries including India.

Dr. Reddy's Laboratories Ltd. announces partnering with FUJIFILM Corporation through FUJIFILM Toyama Chemical Co. Ltd.  and Global Response Aid for the development, manufacture and sales of Avigan® Tablets (generic name: favipiravir), a potential treatment of COVID-19.

Dr. Reddy’s Laboratories Ltd. announces the launch of its advanced B2B Customer Service Portal “XCEED.”