Dr. Reddy’s API Research and Development Capabilities

As an industry-leading active pharma ingredient manufacturer and an active pharmaceutical ingredient supplier of generic APIs, Dr. Reddy’s is a partner for pharma companies in more than 80 countries. Our strong R&D 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. Furthermore, our pharma research and development expertise has enabled us to develop a strong portfolio in key therapy areas, including oncology, cardiovascular, central nervous system, gastrointestinal system, etc. Our capabilities include contained (Highly potent APIs) and non-contained APIs at laboratory, pilot, and production scales. In addition, we have the expertise to perform standard chemical reactions, route scouting, pharmaceutical development and technology, optimization, QbD implementation, solid-state characterization, polymorph screening, chiral chemistry, biocatalysis, and chemo-catalysis.

Dedicated R&D Centers

Our API commercial production facilities are equipped with state-of-the-art equipment, incorporating years of process optimization, and are supported by multi-purpose plants for key starting materials and intermediates, with stringent quality control systems and extensive experience in regulatory procedures established marketing and distribution infrastructure. 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. We have dedicated R&D centers for high potent APIs, complex APIs, prostaglandins, steroids, and 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.
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Dedicated R&D Centers

Since 2010, Dr. Reddy’s Laboratories Ltd 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.
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Our R&D Capabilities - Complex API’s and Services Supporting Early Market Entries

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Experience with complex APIs and formulations (such as Eribulin, Fondaparinux, Iron compounds, etc.)

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Innovative drug delivery platforms such as microspheres, liposomes, nanoparticles, etc.

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Multiple IP-driven formulations for early launch opportunities.

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Robust technology platforms such as synthetic/semi- synthetic peptides, chiral chemistry.

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New formulations - e.g., ready to use.

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Steroids, semi- synthetic/fermentation, unnatural amino acids, prostaglandins, pegylation technology. and flow chemistry

Our R&D Centres are Equipped With:

cGMP compliant isolator systems for high potent raw materials, intermediates charging, filtration and drying, dispensing, and packaging Protecting the environment, people, and product - Dr. Reddy’s can handle molecules of OEL up to 0.1 µg/m3. Our Team of R&D experts developed processes and 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). Our experienced team of API and formulation experts supports you beyond API supply, ensuring successful formulation. Quality by design (QbD) based development skills in chromatography. Effective API pharma manufacturing process development with high-quality standards to meet regulatory requirements. Different purification approaches impurity profiling and characterization to meet the standards of the RLD. Process optimization and robust process in pharmaceutical development and technology. Deep knowledge in downstream purification and isolation. Applications of PAT (Gradient with NIR based) during development for chromatography and lyophilization.

Going Beyond APIs with Generic Formulation Offerings to Complement Your Capabilities

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We are vertically integrated from producing APIs to formulations.

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Highly experienced and integrated technical team to support from filing-to-launch.

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Backed by one of the best manufacturing bases in India for a seamless execution.

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Super specialty products in therapy areas such as Central Nervous System (CNS), cardiovascular, and Oncology (Oral and Injectable)

Models of Collaboration:

Dossier + API supply

Dossier + API supply

Dossier + Formulation supply

Dossier + Formulation supply

Dossier + Tech Transfer + API supply

Dossier + Tech Transfer + API supply

Semi-finished product supply

Semi-finished product supply

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.

FAQs

What is Active pharmaceutical ingredient in Pharmaceutical Industry?
  • 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.”

What are the critical steps involved in manufacturing operations of API?
  • 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.

What are the Regulations on APIs?
  • 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.

What is the current market growth for Pharmaceutical APIs ?
  • 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.

We are here to help, if you have any country specific requirements.

Meet with our product experts in one-on-one virtual sessions

Our experts will answer your questions, provide advice, Global Generics & stress timelines and help you understand our product better

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.