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Leading Pharmaceutical API Manufacturing Company

The ready availability of high-quality, affordable active pharmaceutical ingredients (APIs) is critical to the delivery of good health to all.

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 US, Europe, Latin America, Japan, China, Korea and emerging markets.

Our business thrives on the deep technical strengths established over the last 40+ years in the development and manufacture of complex APIs 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 regulatory standards.

1984

Founded by Dr. Anji Reddy - The company’s first molecule was methyl-dopa, a hyper-tension drug that was unavail-able in India until 1984. The API has been supplied to leading pharma companies worldwide.

1991

From APIs to Formulations – Launch of Omez (Omeprazole). Dr. Reddy’s adds formulation capabilities

1995

Expansion into US, Europe, Russia and EM

2001

First Asia Pacific pharmaceutical company outside Japan to list on the New York Stock Exchange

Dr. Reddy’s announced the launch of Amlodipine Benazepril in the US market.

Dr. Reddy’s launches the first biosimilar darbepoetin alfa in the world and brings relief to millions of anaemia patients and in India under the brand name 'Cresp®', the only one in India.

In the Active Ingredients business, the company filed 36 Drug Master Files (DMFs) in 2009-10. As on 31 March 2010, Dr. Reddy’s had cumulative filings of 378 DMFs, with 156 in the US.

Dr. Reddy’s announced the launch of Pantoprazole Sodium delayed-released tablets.

Dr. Reddy’s launched Levocetirizine tablets, a bioequivalent generic version of Xyzal® in US market.

On October 23, Dr. Reddy’s received an approval and was awarded a 180-day of marketing exclusivity from US FDA for olanzapine 20 mg tablet.

Dr. Reddy’s announced the launch of Atorvastatin Calcium Tablets, a bioequivalent generic version of LIPITOR® in the US market.

Dr. Reddy’s announced the launch of Metoprolol Succinate ER (Extended-Release) Tablet, a bioequivalent generic version of TopropXL® tablets in the US market.

Dr. Reddy’s announced the launch of Zenatane™ (Isotretinoin Capsules USP), a therapeutic equivalent generic version of Accutane® in the US market.

Dr. Reddy’s announced the launch of Divalproex Sodium Extended-Release Tablets, USP, a therapeutic equivalent generic version of Depakote® ER tablet in the US market.

104 new generics products were launched.

577 DMFs were filed in FY2012-13.

Dr. Reddy's Laboratories announces the launch of Hervycta® (trastuzumab biosimilar) in India.

Dr. Reddy's Laboratories receives approval for Aspirin and Extended-Release Dipyridamole Capsules in the U.S. Market.

Dr. Reddy's Laboratories announces first-to-market launch of Carboprost Tromethamine Injection USP, 250 mcg/mL (1mL) Single-dose Vial in the U.S. Market.

We are the First Indian Pharma Company to win the national tender for supply of one of the generic drugs (Olanzapine), in China.

Dr. Reddy's Laboratories announces first-to-market launch of Naloxone Hydrochloride Injection USP, 2 mg/2 mL (1 mg/mL) Single-dose Prefilled Syringe in the U.S. Market.

Dr. Reddy’s Laboratories announces the launch of FXR™ (obeticholic acid) in India.

Dr. Reddy's Laboratories announces the launch of AVIGAN® (Favipiravir) in India.

Dr. Reddy's Laboratories announces the launch of Redyx in India.

Our Capabilities

R&D

Dr. Reddy’s comprises a strong technical and cross-functional teams including R&D, Quality, Engineering & Analytical departments. Our dedicated R&D teams are committed to developing complex products to meet the evolving API needs in the GMP environment.

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Regulatory

Dr. Reddy’s have an unmatched global regulatory expertise focused on international markets. Our top-class quality and industry-leading compliance are designed to ensure our products meet stringent regulatory requirements globally. Our APIs have regulatory filings available in major markets across the world.

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API Manufacturing

Dr. Reddy's manufactures a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 180+ active pharmaceutical ingredients (APIs). Our API manufacturing facilities are operated following cGMP (ICH Q7) and regularly inspected by international regulatory authorities. We have eight commercial USFDA inspected production units, six in India and one in Mexico and the UK.

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Sustainability & Social Responsibility

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.

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.

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

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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.

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.