Active Pharmaceutical Ingredients - Medicine Manufacturing Active Pharmaceutical Ingredients - Medicine Manufacturing

Research & Development

Creating high quality API

Active Pharmaceutical Ingredients

Taking utmost care to understand the needs of our customers enables us to develop and deliver innovative products at an affordable cost to all sections of the society. Mankind has over 1,000 products being marketed and 200+ products under development. Our product portfolio caters to a wide array of therapeutic areas such as Cardiology, Neurology, Gastroenterology, Pulmonology, Diabetology, Dermatology, Ophthalmology, Gynecology, and many more.

About API business

Mankind is one of the top producers of Active Pharmaceutical Ingredients. Mankind enables global innovators and generic pharmaceutical companies to be the first to take their finished products to the market by providing end-to-end support.

To help patients get access to affordable and innovative medicines, Mankind focuses on developing high-quality Active Pharmaceutical Ingredients. Drawing on its expertise and capabilities in innovative research and development, Mankind formulates NCEs, generic APIs, Steroids, Advanced Intermediates, for domestic, semi-regulated and regulated markets.

Mankind manufactures a variety of APIs using a combination of processes in order to diversify its product range and product mix in response to the changes in consumer demand and to serve consumer requirements, ranging from laboratory scale research to commercial production.

Mankind is equipped with cutting-edge infrastructure to conduct several complex reactions in a cost-effective manner with a flexible and varied scale of operations and weight capacities.

Research and Development

The API business is supported by state-of-the-art three R&D centres where is close to 350+ scientist are working continuously to synthesis a cost-effective and innovative process.

These complex reaction capabilities include Grignard, Swern oxidation, vilsmeir hack reaction, Friedel-Craft alkylation, asymmetric reactions and reductions, cryogenics, cyanation, enzymatic, chlorination, carboxylation, hydrogenation and organoborane chemistry. They are regulated across lab-scale, pilot-scale and commercial scale and can also conduct pyrophoric and hazardous reagents at very low temperatures.

By maintaining cost leadership and competitiveness in various therapeutic domains, Mankind’s API has ensured the profitability and growth of the company's formulations and made it a global API supplier.

  • Intellectual Property
    A team of experienced IP team work closely with R&D to develop an innovative process. IP team also provides extensive support to global generic companies in evaluating patent landscape across the globe. Mankind is having a catalogue of close to 50 patent grant/publications.
  • Regulatory Affairs

    Mankind in-house regulatory team is experienced to understand the regulatory requirements of various markets.

    Regulatory team has an expertise to file DMFs and handle regulatory and customer’s deficiencies across the markets including most regulated markets US, EU, Japan and Brazil. The DMFs are prepared and filed in line with the latest regulatory requirements.

    Regulatory team at Mankind provides on-time support to our global esteemed customers for timely response to regulatory agencies.

  • Manufacturing Infrastructure
    Mankind is having two API and intermediate manufacturing sites as per cGMP requirement. Our manufacturing facilities meet regulatory requirements of EU, US and Japan and various other markets. Most of APIs are manufactured between the two sites from basic starting material enable us to have complete control on GMP and quality.
API capabilities
  • 2 API manufacturing facilities
    • Shree Jee Laboratory Ltd
    • JPR Laboratories Limited
  • Both plant follow same quality system as per Mankind Global SOP
  • Back to forward integration of process
  • Supported by in-house API R&D capabilities and IP

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