Empagliflozin API Manufacturers & Suppliers in India

Empagliflozin API is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney. It is used clinically as an adjunct to diet and exercise, often in combination with other drug therapies, for the management of type 2 diabetes mellitus. As the most recently approved of the “flozin” drugs, empagliflozin carries the highest selectivity for SGLT2 over SGLT1 (approximately 2700-fold). Empagliflozin API was further approved by the EMA in March 2022 and Health Canada in April 2022, making it the first and only approved treatment in Europe and Canada for adults with symptomatic chronic heart failure regardless of ejection fraction

Product Description

Generic Name: Empagliflozin API

Chemical Name : (2S,3R,4R,5S,6R)-2-[4-chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol

Molecular weight: 450.91 g/mol

Molecular formula: C23H27ClO7

Category: sodium-glucose co-transporter (SGLT-2)

Therapeutic use:  Used to treat type 2 diabetes

Form: Crystalline solid

Color: White to yellow

Size of package: As per requirement

Synonyms: (1S)-1,5-Anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol, BI-10773, and 1-chloro-4-(glucopyranos-1-yl)-2-(4-(tetrahydrofuran-3-yloxy)benzyl)benzene

Solubility: Sparingly soluble in methanol, soluble in acetonitrile and water (1:1)

Empagliflozin API Specification

  • ☐ Total impurities: Not more than 1.0%
  • ☐ Any Unspecified Impurity: Not more than 0.1%
  • ☐ Loss on Drying at 105 deg C for 3 hr: Not more than 0.5 %w/w
  • ☐ Residue on Ignition: Not more than 0.1 %w/w

Quality Standards and Manufacturing Excellence of Bio-Synth

Bio-Synth operates with an unwavering commitment to quality. Our manufacturing processes integrate

  • ☐ WHO-GMP (Good Manufacturing Practices) compliance
  • ☐ ISO 9000:2015 certification
  • ☐ Adherence to ICH guidelines and pharmacopeia standards

 Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence.

Applications of Empagliflozin API

Empagliflozin API is used to improve glycemic control in patients aged 10 years and older with type 2 diabetes along with diet and exercise. It is also indicated to reduce the risk of cardiovascular death in adult patients with both type 2 diabetes mellitus and established cardiovascular disease, either alone or as a combination product with metformin

Therapeutic Uses and Indications of Empagliflozin

Empagliflozin is used along with diet and exercise, and sometimes with other medications, to lower blood sugar levels in adults and children 10 years of age and older with type 2 diabetes (a condition in which blood sugar is too high because the body does not produce or use insulin normally). Empagliflozin is also used to reduce the risk of stroke, heart attack, or death in people who have type 2 diabetes along with heart and blood vessel disease. Empagliflozin is also used in adults with heart failure to reduce the risk of needing to be hospitalized and death due to heart and blood vessel disease. It is also used to reduce the risk of worsening kidney disease, the need to be hospitalized, and the risk of death due to heart disease in adults with kidney disease.

How Empagliflozin API Works (Mechanism of Action)

Empagliflozin API works by inhibiting the sodium-glucose co-transporter-2 (SGLT-2) found in the proximal tubules in the kidneys. Through SGLT2 inhibition, empagliflozin reduces renal reabsorption of glucose and increases urinary excretion of glucose.

Why Choose Bio-Synth for Empagliflozin API

Bio-Synth adheres to stringent quality protocols to ensure that each batch of Empagliflozin API meets comprehensive global quality standards. Our robust quality control practices confirm the purity, potency, and safety of our products, ensuring reliable therapeutic results. We manufacture Empagliflozin API in our 60kL WHO-GMP, ISO certified facility with a capacity of 2.5 tons/month.

Bio Synth: Empagliflozin API Suppliers in India

io-synth is one of the leading API manufacturers in India that has included Empagliflozin API in its product portfolio. Bio-synth manufactures all intermediates of Empagliflozin API in-house, thereby offering the best quality, price and lead time.

Empagliflozin API Price in India

Bio Synth is a reputable supplier of pharmaceutical APIs and intermediates, including Empagliflozin API, used to treat type 2 diabetes. Bio-Synth offers Empagliflozin API at highly competitive prices tailored to your specific requirements. We ensure the best value while maintaining the highest quality standards. For detailed pricing and further inquiries, please reach out to us directly, and our team will be happy to assist you.

Frequently Asked Questions

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    Empagliflozin API is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that is used to treat type 2 diabetes

    Bio-Synth offers premium-quality Empagliflozin API at competitive prices, tailored to meet your specific requirements. By handling all production stages internally, we maintain strict control over quality while optimizing pricing. For accurate pricing and to discuss your specific needs, we encourage you to reach out with your inquiry. Our team is dedicated to providing timely responses and ensuring your complete satisfaction./p>

    Bio-synth is one of the top manufacturers of APIs in india. We also have a manufacturer of Empagliflozin API in India, offering top quality, competitive prices, and short lead time.

    Empagliflozin API is used in the development of medications to manage to treat type 2 diabetes. It also supports cardiovascular and renal health.

    The chemical composition of Empagliflozin API is C23H27ClO7, which stands for (2S,3R,4R,5S,6R)-2-[4-chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6-(hydroxymethyl)oxane-3,4,5-triol

    Yes, Empagliflozin API is available for purchase in India. Bio-synth is one of the leading manufacturers and suppliers of the product. Please reach out via the enquiry form with your requirement and we will be happy to assist you.

    Bio-synth has almost 8 decades of experience manufacturing high-quality APIs, with Empagliflozin API as one of the key products in its product portfolio, making Bio-Synth a trusted API manufacturer in India.

    Bio-Synth offers high-quality Empagliflozin API that meets global standards like WHO-GMP and ISO 9000:2015 certification. Our rigorous quality control ensures a consistent and reliable Empagliflozin API supply, making us a top choice for Empagliflozin API suppliers in India.

    Our facilities are equipped with cutting-edge technology and maintain strict adherence to GLP (Good Laboratory Practices), GDP (Good Documentation Practices), and cGMP (Current Good Manufacturing Practices). This results in consistent product quality, reinforcing Bio-Synth’s reputation for excellence.

    To place an order for Empagliflozin API, contact Bio-Synth through our customer service team or by filling out the contact form on our website. We provide comprehensive support to guide you through the order process and ensure timely delivery to meet your specific needs.