We manufacture our Anti-cancer APIs at cGMP API manufacturing facilities which are successfully inspected by international regulatory authorities such as the USFDA, EMEA, ANVISA, PMDA, and Health Canada.
Our team of process experts draws on their integrated understanding of IP, process development (API and formulation), and API manufacturing to ensure that by design, the process is lean, free from potential genotoxic impurities, and scalable to manufacture for early market entries. This is of particular importance to select the optimal synthesis route in the context of the IP situation. Other aspects are the solid-state forms and particle characteristics that are critical in formulation development.
We have incorporated sensitive and rigorous analytical methods to control the impurities at a specified level and extensively studied the flow properties, crystal size/shape, and morphology in accordance with future requirements. In addition, our APIs have been designed to address customized PSD requirements through size reduction and crystallization techniques, resulting in a high probability of successful formulation development.
Dr. Reddy, is well-positioned to meet the global demand for Anti-cancer/Oncology APIs. As for many of our APIs. the key starting materials (KW) are backward integrated today. We've also established strategic solid sourcing and logistics partnerships and work closely with our customers to successfully manage Me capacities of our manufacturing units ahead of launches.
To know more about our end-to-end solutions for Anti-cancer/Oncology APIs formulations and Dosage forms. Check out our board portfolio of Anti-cancer/Oncology APIs here (Link) (or) Contact us at api@drreddys.com
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.”
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.
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. The final API the progresses towards appropriate characterization and analytical techniques.
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.
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 & screen the APIs thoroughly to ensure medication quality as per the regulatory standards. Violating any of these regulatory standards or procedures can result in huge fines.
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&D, chronic diseases, the demand for generics, and the increasing uptake of biopharmaceuticals.
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.