Experience with complex APIs and formulations (such as Eribulin, Fondaparinux, Iron compounds, etc.)
Innovative drug delivery platforms such as microspheres, liposomes, nanoparticles, etc.
Multiple IP-driven formulations for early launch opportunities.
Robust technology platforms such as synthetic/semi- synthetic peptides, chiral chemistry.
New formulations - e.g., ready to use.
Steroids, semi- synthetic/fermentation, unnatural amino acids, prostaglandins, pegylation technology. and flow chemistry
We are vertically integrated from producing APIs to formulations.
Highly experienced and integrated technical team to support from filing-to-launch.
Backed by one of the best manufacturing bases in India for a seamless execution.
Super specialty products in therapy areas such as Central Nervous System (CNS), cardiovascular, and Oncology (Oral and Injectable)
To know more about our products or order a sample, meet with our product experts in one-on-one virtual sessions here. For details on the offer ability of products for your market of interest, please reach out to 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.
Our experts will answer your questions, provide advice, Global Generics & stress timelines and help you understand our product better
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.