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18:T42c,<p>The ready availability of high-quality, affordable active pharmaceutical ingredients (APIs) is critical to the delivery of good health to all.</p><p>The Dr. Reddy’s API business supplies high quality affordable APIs to leading generic formulations manufacturers across the world, enabling them to accelerate access to affordable medicines for patients worldwide. We are the preferred API partner to pharma companies across the <a href="https://drl-api.projectmgi.in/about#">US</a>, Europe, Latin America, Japan, China, Korea and emerging markets.</p><p>Our business thrives on the deep technical strengths established over the last 40+ years in the development and manufacture of complex <a href="https://drl-api.projectmgi.in/about#">APIs</a> such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAIs /oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed <a href="https://drl-api.projectmgi.in/about#">regulatory standards</a>.</p>1c:T5bc,<p>We believe that our strength in innovation, ethical values and focus on bringing critical, life-saving products early to market secures a unique kind of sustainability for us. Our leadership across global markets is indicative of our strong alignment with our ‘Good Health Can’t Wait’ agenda. While we renewed our goals in 2020 to adapt to changing stakeholder expectations, address climate change, and our resolve to work on material issues, we continued to examine more ways to make an impact. We consulted a larger set of global sustainability and pharmaceutical standards and frameworks, and these findings guided our ESG reviews with the leadership and Board.</p><p>Combining a top-down and bottom-up approach, using more tools such as our updated enterprise risk management findings, we set 14 bold and ambitious goals across the ESG dimensions to form our vision for 2030. Each of these goals takes into consideration our critical material topics, the external environment in which we operate, and the business and social impact that we can create. In our core API business, our focus on innovation-led affordability gives our customers access to the most complex active ingredients, while maintaining a consistent global quality standard. Our partnerships with leading generic formulation brands to fulfil their drug development needs has also given an edge to our own generics business, enabling us to deliver higher quality at competitive costs.</p>20:T42d,<p>API manufacturers are expected to apply CGMPs to the API process beginning with the use of starting materials, and to validate critical process steps that impact the quality and purity of the final API. Controls over material quality are expected to increase as the process approaches the final API. The level of control needed is highly dependent on the manufacturing process and increases throughout the process as it proceeds from early intermediate steps to final isolation and purification steps. The appropriate level of control depends on the risk or criticality associated with each specific process step.<br>An API process is a related series of operations which result in the preparation of an active pharmaceutical ingredient. Major operations or steps in an API process may include multi-step chemical synthesis and fermentation, purification, crystallization, drying, milling, packing, labelling, and testing. 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It is an inhibitor of the JAK1 and JAK2 protein kinases and works by competitively inhibiting the ATP-binding catalytic site on JAK1 and JAK2.</p>","image":"https://admin.projectmgi.in/sites/default/files/2025-05/tab-img-4_3.jpg"},{"content":"<p>Dr. Reddy's is an early mover in API development and planning to file the DMFs in key markets such as the US, China, Japan, Brazil, Europe, and Korea. We offer the anhydrous crystalline form (Innovator form).</p>","image":"https://admin.projectmgi.in/sites/default/files/2025-05/tab-img-3_3.jpg"}]},{"nid":"13","resource_title":"Articles","resource_main_image":"https://admin.projectmgi.in/sites/default/files/2025-05/tab-img-1-mainbanner_0.jpg","icon":"https://admin.projectmgi.in/sites/default/files/2025-05/resource-2.png","resource_content":"<p>An active pharmaceutical ingredient is defined in ICH Q7 as “any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body</p>","download_link":"","resource_all_link":"","small_banner_contents":[{"content":"<p>The Active Pharmaceutical Ingredient (API) industry is a cornerstone of the global pharmaceutical sector, responsible for producing the essential components that give medications their therapeutic effects.</p>","image":"https://admin.projectmgi.in/sites/default/files/2025-05/Article_2.jpg"},{"content":"<p>One of the primary objectives of global regulations is to ensure the quality and safety of APIs. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA)</p>","image":"https://admin.projectmgi.in/sites/default/files/2025-05/article_1.jpg"},{"content":"<p>The API industry must navigate a myriad of regulatory challenges that vary by region. For instance, the FDA's Current Good Manufacturing Practice (CGMP) guidelines are particularly rigorous, requiring manufacturers to maintain high standards of cleanliness, employee training, and documentation2.</p>","image":"https://admin.projectmgi.in/sites/default/files/2025-05/article_3.jpg"}]},{"nid":"15","resource_title":"News","resource_main_image":"https://admin.projectmgi.in/sites/default/files/2025-05/pharma-excellence-awards-2025-pic-03.png","icon":"https://admin.projectmgi.in/sites/default/files/2025-05/resource-4.png","resource_content":"<p>We are thrilled to announce that Dr. Reddy's Laboratories has been honored with multiple accolades at the Express Pharma Excellence Awards 2025. These prestigious awards recognize our excellence in three key categories:</p><ol><li><strong>Export Powerhouse (FY24) Finished Formulations:</strong> Celebrating our global reach and impact in delivering high-quality finished pharmaceutical products.</li><li><strong>Market Trailblazers:</strong> Acknowledging our innovative strategies and leadership in the pharmaceutical market.</li><li><strong>Export Powerhouse (FY24) APIs &amp; Intermediates:</strong> Highlighting our strength in exporting active pharmaceutical ingredients and intermediates worldwide.</li></ol>","download_link":"","resource_all_link":"","small_banner_contents":[{"content":"<ol><li><strong>Export Powerhouse (FY24) Finished Formulations:</strong> Celebrating our global reach and impact in delivering high-quality finished pharmaceutical products.</li></ol>","image":"https://admin.projectmgi.in/sites/default/files/2025-05/pharma-excellence-awards-2025-pic-04.jpg"},{"content":"<p><strong>Market Trailblazers:</strong> Acknowledging our innovative strategies and leadership in the pharmaceutical market.</p>","image":"https://admin.projectmgi.in/sites/default/files/2025-05/pharma-excellence-awards-2025-pic-01.jpg"}]},{"nid":"14","resource_title":"Webinars","resource_main_image":"https://admin.projectmgi.in/sites/default/files/2025-05/tab-img-1-mainbanner_1.jpg","icon":"https://admin.projectmgi.in/sites/default/files/2025-05/resource-3.png","resource_content":"<p>Supply disruptions due to Covid-19 and raw material shortages have significantly impacted pharmaceutical organizations. Increasing demands and limitations in logistics and courier services further tested the supply chains. With new challenges and various environmental factors coming into place, pharmaceutical organizations have embarked on adopting digital analytics , new collaborations with government agencies , focus on sustainable supply chain, and changing the organization's internal structure for focused decision making.</p>","download_link":"","resource_all_link":"","small_banner_contents":[{"content":"<p>In this Webinar, Dr. Reddy's in collaboration with Sindusfarma, brings the expertise of specialists in the areas of organic synthesis and API production, toxicology, regulatory, and sanitary actions in the view of ANVISA; to discuss the topic – \"Sartans: New Mutagenic Impurities - Azido Impurities.\"</p>","image":"https://admin.projectmgi.in/sites/default/files/2025-05/raphael.jpg"},{"content":"<p>In the first section of the Webinar, Ms. Fernanda Waechter, Principal Application Scientist, Lhasa Limited, talks about - Azido and nitrosamine impurities: formation, similarities, differences, and their carcinogenicity.&nbsp;</p>","image":"https://admin.projectmgi.in/sites/default/files/2025-05/Rakeshwar_Bandichhor.jpg"},{"content":"<p>In the next section, Rakeshwar Bandichhor, Ph.D., FRSC, CChem, VP, and Head of Chemistry, API-PR&amp;D, elaborates on the Workflow and risk assessment to deal with these impurities. In addition, he talks about the alkyl azide chemistry connected with biology (potential mutagenicity), The chemistry behind Azido impurities formation in Sartan APIs, and the control strategy for Azido impurities in key starting materials (KSMs) of Valsartan.</p>","image":"https://admin.projectmgi.in/sites/default/files/2025-05/fernenda.jpg"}]}]}],["$","$L1f",null,{"faqContent":[{"nid":"28","question":"What is Active pharmaceutical ingredient in Pharmaceutical Industry?","answer":"<p>An active pharmaceutical ingredient is defined in ICH Q7 as “any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body.”</p>"},{"nid":"29","question":"What are the critical steps involved in manufacturing operations of API?","answer":"$20"},{"nid":"30","question":"What are the Regulations on APIs?","answer":"<p>Each country will have its regulatory authority that continuously monitors the drug development process, licensing, registrations, marketing, and labelling of the products. Some of the notable regulatory bodies are as follows: USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), etc.<br>The quality of APIs has a significant effect on the efficacy and the safety of medications. Poorly manufactured or adulterated APIs are associated with health issues, illness, or death. So, to ensure the quality and prevent the defects of APIs, regulatory bodies impose stringent rules &amp; screen the APIs thoroughly to ensure medication quality as per the regulatory standards. Violating any of these <a href=\"https://api.drreddys.com/regulatory\">regulatory standards</a> or procedures can result in huge fines.</p>"},{"nid":"31","question":"What is the current market growth for Pharmaceutical APIs ?","answer":"<p>The global API market size is expected to reach USD 247.3 billion by 2025 from USD 185.3 billion in 2020, at a CAGR of 5.7%. Market growth will be steered by factors such as rising drug R&amp;D, chronic diseases, the demand for generics, and the increasing uptake of biopharmaceuticals.</p>"}]}],["$","$L21",null,{"aboutDisclam":{"nid":"24","disclaimer_text":"<p>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.</p>"}}]]}]
