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Dr. Reddy's API Presence in the USA
Dr. Reddy's API business thrives on the deep technical strengths proven over the last three decades in developing and manufacturing complex APIs. Our API business caters to leading innovators and generic companies in the US markets. Our API manufacturing plants are complemented by formulation manufacturing facilities that can supply various dosage forms. Our API production spans major therapeutic categories, including gastrointestinal, cardiovascular, pain management, oncology, anti-infectives, pediatrics, and dermatology. In addition, an ever-growing API product pipeline promises even more life-changing medicines in the future.
As emerging formulations and advanced therapeutics become available in the future, Dr. Reddy's will continue to build one of the largest offerings in the industry and bring value to its formulators and customers in the USA. Dr. Reddy’s API division is strategically working towards becoming the number one API company in the world by focusing on strong innovation, global footprint, and exceptional customer service. As one of the top API manufacturers in USA driven by consistency and the increasing need for good health, we are committed to improving access to our APIs across the United States.
Our Capabilities
API manufacturing
We have eight commercial USFDA inspected manufacturing units, of which 6 are in India, and one in Mexico and the UK. In addition, we have development facilities in Hyderabad, India and Cambridge, UK, as well as cGMP API manufacturing facilities in India, Mexico, and the UK. As one of top API manufacturing companies in USA our API manufacturing facilities are operated in accordance with cGMP (ICH Q7) and are regularly inspected/audited by international regulatory authorities.
Our exemplary R&D and regulatory compliance record of accomplishment is testimony to the fact that all our facilities are USFDA approved and major regulatory bodies such as WHO GMP, MHRA, EMA, TGA, ANVISA, PMDA, COFEPRIS, etc.
Robust Supply chain
As a top API suppliers in USA our supply chain process is based on a strategic model to ensure a practical, reliable, and sustainable supply of goods and services based on a segmented operation. A scorecard is generated for all the KPIs, and we monitor the progress toward each goal. In addition, a well-defined Supplier Code of Conduct (SCOC) governs our supply chain management. We also have a dedicated SCM (Supply Chain Management) team that addresses all sustainable sourcing elements with special emphasis on supply continuity, quality and compliance, supplier relationships, capacity and capability building, supplier, and performance management, and aligning the partners with our vision of sustainability.
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Strong partner network
Intelligence to get early alerts on issues, enabling us to take corrective actions.
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Cross-industry collaboration groups
Support groups of transporters, shippers, airlines, etc., came together for information sharing and solutions
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Opening ourselves to new possibilities
Adopting new solutions such as moving cold chain products by road and sea, expanding our logistics footprint to new ports and airports, introducing new origin and destination pairs, and exploring digital technology (e.g., digital signatures for regulatory documents).
Dr. Reddy's won the "CII Scale Supply Chain and Logistics Award (scale) 2021" for the 7th consecutive year for the integrated business planning initiative in the pharmaceutical category. The award was presented on the criteria of best practices, sustainability initiatives, and innovations implemented by Dr. Reddy's supply chain and logistics team.
Research and Development
Our strong capabilities in synthetic chemistry, analytical chemistry, and process engineering have helped us build a strong portfolio of small molecule APIs across niche areas, including peptides, carbohydrates, prostaglandins, steroids, and highly potent APIs. In addition, this expertise has enabled us to develop a strong portfolio in key therapy areas, including oncology, cardiovascular and central nervous system. Our capabilities include Complex Chemical Synthesis, HPAPIs, Peptides, Carbohydrates, and steroids.
As a pharma API company, we have dedicated R&D centers for highly potent APIs, complex APIs, prostaglandins, steroids, synthetic and semi-synthetic products. Our R&D capabilities of innovative process development, cost-effective technology development, and stronghold on complex chemistry have helped us to become the partner of choice for global players in the industry.
Our Peptide API Capabilities
We have identified complex generics as our key focus area. Accordingly, we have developed, filed, and offered our customers niche and difficult-to-make molecules involving complex chemistry and characterization. As a peptide API manufacturer, Dr. Reddy's has proven capabilities in synthesizing complex peptides, employing a solid-phase or solution-phase synthesis or a hybrid approach utilizing the QbD framework.
We can scale up and synthesize various peptides ranging from a few grams to multi-kilogram levels with technical expertise, modelling, and simulation techniques. Our portfolio of peptides currently includes Semaglutide, Liraglutide, Icatibant Acetate, Bivalirudin, Aviptadil, Lanreotide, Calcitonin, Abaloparatide with others under development.
Regulatory Capabilities
Dr. Reddy's has unmatched global regulatory expertise focused on international markets. Our top-class quality and industry-leading compliance are designed to ensure our products meet stringent requirements globally. Our Regulatory Affairs team is one of the strongest in the industry, with a dedicated and region-specific team comprising more than 50+ experts in regulatory affairs.
With our regional solid / localized regulatory strengths across the globe – USA, Europe, China, Brazil, and Japan we can cater to the region-specific needs of the customers and assist in DMF fillings and documentation. In addition, Dr. Reddy's global regulatory team is well-versed in submissions in all regulatory markets that support local and worldwide market access strategies with broad market research and deliver high-quality regional-specific DMFs to meet the regulatory requirements.
Our team of regulatory experts understands the complex issues associated with regulatory agencies and assists in approving each complex API production by analyzing the latest regulatory trends and quality requirements through active monitoring and proactive assessment of potential risks.
Our Sustainability Framework
At Dr. Reddy's, we are committed to taking meaningful action for a sustainable future. With our long-standing commitment to protecting the environment, we are working on solutions that help minimize the impact of our operations, driving improvements in multiple areas at various stages of the product life cycle.
Looking at issues of maximum importance to our stakeholders and the business, we are in the process of identifying material issues and building our strategic sustainability framework. We will develop ambitious goals and management targets for each focus area, with multiple milestones, incorporating governance systems and processes, monitoring, and disclosing our performance for each goal, and ensuring independent third-party assurance.
We are determined to play our part in upholding the more prominent global perspective. We will align ourselves with the United Nations' sustainable development goals (UN SDGs), mapping them with our top material issues, allocating internal resources, taking relevant actions, and building technical capabilities. We are also working on greater integration of ESG into our business and building stronger stakeholder relationships by intensifying dialogue and communicating our vision and progress around material issues.
The ESG principles underlie our business strategy. We address customer needs and create value for all stakeholders by addressing unmet needs. We are conscious of our footprint and impact and believe that addressing sustainability challenges is the need of the hour. Therefore, we continue to follow the best practices to make our business more sustainable.
Our Achievements
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Ranked ninth in the Dow Jones Sustainability Index (DJSI) 2021 among the most sustainable pharmaceutical companies in the world for the sixth consecutive year.
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Featured in the Emerging Markets category for the sixth year in a row and among the top 10 sustainability leaders listed in the DJSI.
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We are among the top 10 sustainability leaders, as listed in the DJSI.
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Dr. Reddy's is number 1 in pharmaceuticals as per CRISIL's ESG score rating of 225 Indian companies.
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We are among the top 15% of the pharmaceutical industry as featured in S&P Global's "The Sustainability Yearbook 2021".
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We are listed in the sustainability yearbook of S&P 2022 for the second year in a row and in the Bloomberg Gender-Equality Index (GEI) for the fifth consecutive year.
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Dr. Reddy's bagged the Sustainable Corporate of the Year title in the 12th edition of Frost and Sullivan and TERI Sustainability 4.0 Awards.
In our sustainability journey, these accolades are humbling and demonstrate that we're on the right track. These awards recognize our consistent performance in the environment, social, and governance (ESG) framework.
R&D Operations Guided by Sustainability Framework
Since 2010, Dr. Reddy's has been committed to the UN Global compact corporate responsibility initiative and its principles in the environment, Sustainability, and green chemistry. As an active pharmaceutical ingredient supplier, our primary goal is to develop products that will provide a reliable supply of products of superior quality for the pharmaceutical industry. Also, we ensure that our APIs are produced using eco-friendly processes so that our customers can sustainably access our APIs.
Addressing the presence of Nitrasoamine and Azido Impurities
Dr. Reddy's has continued to manufacture and deliver APIs in accordance with global regulations to avoid the presence of nitrosamine impurities because of the processes and the analytical methods developed by our experts to avoid nitrosamine and Azido impurities. We stay committed to ensuring we continue providing high-quality and nitrosamine-free APIs to our partners.
To control the Nitrosamine levels of API and drug products, we at Dr. Reddy's have employed data modeling and simulation techniques to deeply understand the related substances' behavior, enabling us to design the control strategy for our API process so that the relevant related substance impurities are within desired limits at each API manufacturing stage. In addition, we also further ensure that the nitrosamine impurities in our drug product meet the latest regulatory guidelines.
Customer service
Dr. Reddys provides its customers with a superior service experience with a platform called XCEED. XCEED will help manage the whole business process in real time. From ordering samples to submitting and tracking their orders, XCEED provides convenience and transparency by providing a platform to interact with Dr. Reddy's interdisciplinary support team, which helps in the timely delivery of the APIs closely.
Key Strengths of Dr. Reddy’s API Business:
Disclaimer
No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.
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