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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 30+ 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

2010

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.

2011

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.

2012

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.

2013

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.

2018

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.

2019

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.

2020

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, 60 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

Our sustainability journey is geared towards creating lasting value for all our stakeholders - shareholders, employees, partners and society – without a trade-off on their mutual or individual interests. The processes that we deploy focus on eliminating waste and conserving natural resources like energy and water. All our plants are 'zero liquid discharge' facilities, which means that all the liquid waste and effluent they generate is treated within their premises and reused. We also co-processed/recycled 91 % of our total hazardous waste and continue to be on course to meet our target of zero hazardous waste to landfill by 2020.

Realizing our responsibility to the people of the communities that we live and work in, we pursue community care with the same efficiency and meticulousness with which we pursue our business to create real opportunities, building capabilities and empowering those who need them in areas of health, education and livelihoods.

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

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.

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Active Pharmaceutical Ingredients

API Supplier of the Year

Global Generics & Biosimilars Awards 2021 winner for 3 consecutive years!

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