Dapagliflozin API Manufacturers and Suppliers in India
Dapagliflozin API, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, was the first of its kind to be approved for managing type 2 diabetes mellitus. It enhances glycemic control by inhibiting glucose reabsorption in the proximal tubule of the nephron, promoting glycosuria when combined with diet and exercise in adults. Investigated as monotherapy or as an adjunct with insulin or other oral hypoglycemic agents.
Dapagliflozin API was originally approved by the FDA on January 8, 2014, for improving glycemic control in adults with type 2 diabetes. In April 2021, it received additional approval to reduce the risks of kidney function decline, kidney failure, cardiovascular death, and heart failure hospitalization in adults with chronic kidney disease.
Product Description
Product Description
Product Description
Generic Name: Dapagliflozin Propanediol Monohydrate
Chemical Name : (2S)-propane-1,2-diol(2S,3R,4R,5S,6R)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol hydrate
CAS Number: 461432-26-8
Molecular weight: 502.98 g/mol
Molecular formula: C21H25ClO6·C3H8O2·H2O
Category: Sodium-glucose co-transporter 2 (SGLT2) inhibitor
Therapeutic use: To treat type 2 diabetes
Form: Powder
Color: White to off-white
Size of package: As per requirement
Synonyms: (1S)-1,5-Anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-D-glucitol, Dapagliflozin (S)-propylene glycol monohydrate, BMS 512148 propanediol hydrate, Dapagliflozin propanediol hydrate, Dapagliflozin compound with (2s)-1,2-propanediol hydrate, Dapagliflozin propanediol, Dapagliflozin propylene glycolate hydrate
Solubility: Soluble in N, N-dimethyl formamide, Dimethyl sulfoxide, & ethanol, Insoluble in water and Cyclohexane
Dapagliflozin API Manufacturers and Suppliers in India
As a trusted leader among Dapagliflozin API manufacturers in India, Bio-Synth offers high-quality, non-sedating antihistamines for the pharmaceutical industry. Known for its fast absorption and minimal drug interactions, Dapagliflozin is effective in type 2 diabetes, heart failure, and chronic kidney disease. Our commitment to innovation and quality positions Bio-Synth as a reliable partner for Dapagliflozin API suppliers in India, providing a comprehensive range of Dapagliflozin-related products.
Dapagliflozin API Specification
The Dapagliflozin API specification ensures that each batch of Dapagliflozin meets global quality standards. As a Dapagliflozin API manufacturer in India, Bio-Synth adheres to strict guidelines to ensure product purity and properties.
- ☐ Total impurities: Not more than 1.0%
- ☐ Single maximum unspecified impurity: Not more than 0.1%
- ☐ Loss on drying: Not more than 1.0% w/w
- ☐ Water content by KF: Between 2.5% and 4.5% 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
These certifications demonstrate our commitment to manufacturing Dapagliflozin API that meets national and international requirements. Our manufacturing excellence, combined with a vision for innovation, ensures that every milligram of Dapagliflozin upholds the company’s legacy of quality and trust
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.
Why Choose Bio-Synth for Dapagliflozin API
Bio-Synth adheres to stringent quality protocols to ensure that each batch of Dapagliflozin 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 Dapagliflozin our 60kL WHO-GMP, ISO-certified facility with a capacity of 2.5 tons/month.
Therapeutic Uses and Indications of Dapagliflozin API
Dapagliflozin API is used together with proper diet and exercise to treat type 2 diabetes. It works in the kidneys to prevent the absorption of glucose (blood sugar). This helps lower the blood sugar level. Dapagliflozin does not help patients who have insulin-dependent or type 1 diabetes.
It is also used to lower the risk of hospitalization for heart failure in patients with type 2 diabetes and cardiovascular (heart or blood vessel) disease or multiple cardiovascular risk factors. This medicine is also used to lower the risk of cardiovascular death, hospitalization, and urgent heart failure visits in patients with heart failure with reduced ejection fraction (the heart is weak and cannot pump enough blood to the rest of the body).
It is also used to lower the risk of worsening kidney disease, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease.
How Dapagliflozin API Works (Mechanism of Action)
Dapagliflozin API inhibits the sodium-glucose cotransporter 2(SGLT2), which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose reabsorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus
Introduction to Bio-synth's Capabilities on Dapagliflozin API
Bio-synth specializes in niche APIs and advanced intermediates for the pharmaceutical industry. As leading Dapagliflozin manufacturers in India, along with numerous other APIs and intermediates, we have a production capacity of 2 MT/month. We adhere to WHO-GMP and ISO 9000 and are in the process of complying with EU-CEP and USFDA. We have a strong R&D and production team that can cater to specific customer requirements.
Advantages and Key Features of Dapagliflozin API
- ☐Effective Glycemic Control: As a potent SGLT2 inhibitor, Dapagliflozin ensures effective blood sugar management by promoting glucose excretion through the urine, providing reliable glycemic control for patients with Type 2 Diabetes.
- ☐ Weight Loss Benefits: Offers additional benefits of modest weight reduction, making it ideal for overweight or obese diabetic patients.
- ☐ Cardiovascular Protection: Reduces the risk of major adverse cardiovascular events, enhancing safety for high-risk individuals.
- ☐ Renal Protective Effects: Slows the progression of diabetic kidney disease, supporting better long-term renal health in patients.
- ☐ Oral Bioavailability: Easily absorbed when taken orally, enabling convenient once-daily dosing for patients.
- ☐ Selective and Targeted Action: Specifically inhibits the SGLT2 transporter in the kidneys, ensuring efficacy with minimal off-target effects.
Why Choose Bio-Synth for Dapagliflozin API
Bio-Synth adheres to stringent quality protocols to ensure that each batch of Dapagliflozin 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 Dapagliflozin our 60kL WHO-GMP, ISO-certified facility with a capacity of 2.5 tons/month.
Top Dapagliflozin API Suppliers in India
Bio-synth is one of the leading API suppliers in India, and Dapagliflozin is one of the key products in its product portfolio. Bio-synth manufactures all intermediates of Dapagliflozin in-house, thereby offering the best quality, price, and lead time.
Applications of Dapagliflozin API
Dapagliflozin is usually prescribed if you have type 2 diabetes. It can also be used to treat:
- ☐Heart Failure: It can reduce the risk of the heart getting weaker, and help symptoms such as tiredness
- ☐ Chronic Kidney Disease: It helps to slow the rate at which the condition gets worse
Dapagliflozin API Price in India
Bio Synth is a reputable supplier of pharmaceutical APIs and intermediates, including Dapagliflozin API, used to treat benign prostatic hyperplasia. Bio-Synth offers Dapagliflozin 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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1. What Is Dapagliflozin API?
Dapagliflozin API is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that is used to treat type 2 diabetes.
2. What Is Dapagliflozin API Used For?
Dapagliflozin API is used in the development of medications to manage to treat type 2 diabetes. It also supports cardiovascular and renal health.
3. How does Dapagliflozin work?
Dapagliflozin works by inhibiting the Sodium-Glucose Cotransporter-2 (SGLT2) in the kidneys, reducing glucose reabsorption and promoting its excretion through urine. This lowers blood sugar levels, aids in weight reduction, and provides additional benefits like improved kidney and cardiovascular health.
4. What is the CAS Number of Dapagliflozin API?
The CAS (Chemical Abstracts Service) Number for Dapagliflozin API is 461432-26-8.
5. What Is The Price of Dapagliflozin API In India?
Bio-Synth offers premium-quality Dapagliflozin 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.
6. Who Is The Top Manufacturer of Dapagliflozin API In India?
Bio-synth is one of the top manufacturers of Dapagliflozin API in India, offering top quality, competitive prices, and short lead time.
7. What Is The Composition of Dapagliflozin API?
The chemical composition of Dapagliflozin API is C₂₁H₂₅ClO₆·C₃H₈O₂·H₂O, which stands for (2S)-propane-1,2-diol (2S,3R,4R,5S,6R)-2-{4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl}-6-(hydroxymethyl)oxane-3,4,5-triol hydrate
8. Can I Buy Dapagliflozin API from India?
Yes, Dapagliflozin 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.
9. Why Is Bio-Synth A Trusted Dapagliflozin API Manufacturer In India?
Bio-synth has almost 8 decades of experience manufacturing high-quality APIs, with Dapagliflozin API as one of the key products in its product portfolio, making Bio-Synth one of the trusted manufacturers in India.
10. Why Bio-Synth For Dapagliflozin API?
Bio-Synth offers high-quality Dapagliflozin API that meets global standards like WHO-GMP and ISO 9000:2015 certification. Our rigorous quality control ensures consistent and reliable Dapagliflozin supply, making us a top choice for Dapagliflozin API suppliers in India.
11. How Does Bio-Synth Ensure Product Quality And Consistency?
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.
12. How Can I Place An Order For Dapagliflozin API?
To place an order for Dapagliflozin 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.
