Resmetirom API Manufacturers And Suppliers in India
Resmetirom is a thyroid hormone receptor-beta (THR-beta) agonist. In March 2024, it was approved by the FDA as the first treatment of liver fibrosis due to noncirrhotic non-alcoholic steatohepatitis (NASH), which is a form of non-alcoholic fatty liver disease (NAFLD). Thyroid hormones directly regulate lipid metabolism in the liver; thus, impaired thyroid function, such as low serum thyroid hormone levels, is often observed in NAFLD. Resmetirom API works to reduce liver fat by stimulating fatty acid degradation and oxidation.
Product Description
Product Description
Product Description
Generic Name: Resmetirom API
Chemical Name: 2-[3,5-Dichloro-4-((6-oxo-5-(propan-2-yl)-1,6-dihydropyridazin-3-yl)oxy)phenyl]-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile
CAS Number: 920509-32-6
Molecular weight: 435.22 g/mol
Molecular formula: C17H12Cl2N6O4
Category: Thyroid hormone receptor (THR)-beta agonists
Therapeutic use: Used in the therapy of nonalcoholic steatohepatitis (NASH) with moderate-to-severe fibrosis
Form: Powder
Color: White to off-white
Size of package: As per requirement
Synonyms: 2-[3,5-dichloro-4-[[1,6-dihydro-5-(1-methylethyl)-6-oxo-3-pyridazinyl]oxy]phenyl]-2,3,4,5-tetrahydro-3,5-dioxo;2-[3,5-Dichloro-4-[[1,6-dihydro-5-(1-methylethyl)-6-oxo-3-pyridazinyl]oxy]phenyl]-2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazine-6-carbonitrile
Solubility: Slightly soluble in acetic acid, sparingly soluble in DMSO and practically insoluble in water
Resmetirom API Specification
- ☐ Total impurities: Not more than 0.5%
- ☐ Any unspecified impurity: Not more than 0.1%
- ☐ Assay by HPLC: Not less than 98% and not more than 102%
Resmetirom API Manufacturers & Suppliers in India
As one of the leading manufacturers of Resmetirom in India, Bio-synth manufactures all intermediates in-house, enabling the highest quality, most competitive prices, and shortest lead times. With 81 years of API & intermediates manufacturing experience, our processes and systems are optimized to deliver the best quality product that matches your requirements
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 Resmetirom API
Resmetirom API is used for treatment of adult patients with nonalcoholic steatohepatitis (NASH; liver inflammation and damage caused by build up of fat in the liver) with moderate to advanced liver fibrosis (changes in liver tissue seen with early liver damage) but not cirrhotic (scarring of the liver that keeps the liver from functioning properly).
Therapeutic Uses and Indications of Resmetirom API
Resmetirom API is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). It is also beneficial in improving lipid profiles and reducing cholesterol levels in patients with metabolic disorders.
How Resmetirom API Works (Mechanism of Action)
Resmetirom API, used for nonalcoholic steatohepatitis (NASH) with fibrosis, works by mimicking the effects of triiodothyronine (T3) and selectively targeting the thyroid hormone receptor beta (THR-β) in the liver. This action reduces liver fat, improves lipid profiles, and can modestly improve fibrosis.
Why Choose Bio-Synth for Resmetirom API
Bio-Synth adheres to stringent quality protocols to ensure that each batch of Resmetirom API meets comprehensive global quality standards. Our robust quality control practices confirm the purity, potency, and safety of our products, ensuring reliable therapeutic results. Our 120kL WHO-GMP, ISO certified facility can manufacture 1 ton/month. Bio-synth manufactures all intermediates of Resmetirom in-house, ensuring superior quality, price, and delivery schedules.
Advantages And Key Features of Resmetirom API
The tissue-specific action of Resmetirom in the liver may contribute to a more favorable safety profile compared to broader thyroid hormone therapies. Additionally, Resmetirom API has shown potential in reducing LDL-C, TG, and non-HDL-C levels and can improve insulin sensitivity by reducing hepatic insulin resistance, potentially beneficial for individuals with metabolic issues.
Bio Synth: Resmetirom API Suppliers in India
Bio-Synth is a trusted Resmetirom API supplier in India, known for its quality manufacturing, cost-effectiveness, and customer satisfaction. With GMP-compliant facilities and timely delivery, Bio-Synth supports pharmaceutical manufacturers with high-purity APIs and reliable service.
Resmetirom API Price in India
Bio Synth is a reputable supplier of pharmaceutical APIs and intermediates, including Resmetirom API, used to help control partial onset seizures in the treatment of epilepsy. Bio-Synth offers Resmetirom 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
We are listening.
We believe that the heart of dialogue is listening. Please write in your queries and we will get back to you.
1. What Is Resmetirom API?
Resmetirom API is the key component in the thyroid hormone receptor (THR)-beta agonist drug used to treat nonalcoholic steatohepatitis (NASH).
2. What Is Resmetirom API Used For?
Resmetirom API is used for treatment of adult patients with nonalcoholic steatohepatitis (NASH; liver inflammation and damage caused by build up of fat in the liver) with moderate to advanced liver fibrosis (changes in liver tissue seen with early liver damage) but not cirrhotic (scarring of the liver that keeps the liver from functioning properly).
3. What Is The Cost of Resmetirom API In India?
Bio-Synth offers premium-quality Resmetirom 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.
4. Who Is The Manufacturer of Resmetirom In India?
Bio-synth is one of the top manufacturers of APIs in India. We also manufacture Resmetirom API, offering top quality, competitive prices, and short lead time.
5. What Is The Composition Of Resmetirom API?
The chemical composition of Resmetirom API is C17H12Cl2N6O4 which stands for 2-[3,5-Dichloro-4-((6-oxo-5-(propan-2-yl)-1,6-dihydropyridazin-3-yl)oxy)phenyl]-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile
6. Can I Buy Resmetirom API From India?
Yes, Resmetirom API is available for purchase in India. Bio-synth is one of the leading manufacturers and suppliers of API products. Please reach out via the enquiry form with your requirement, and we will be happy to assist you.
7. Why Is Bio-Synth A Trusted Resmetirom API Manufacturer In India?
Bio-Synth has almost 8 decades of experience manufacturing high-quality APIs, with Resmetirom API as one of the key products in its product portfolio, making Bio-Synth one of the trusted manufacturers in India.
8. Why Bio-Synth For Resmetirom API?
Bio-Synth offers high-quality Resmetirom API that meets global standards like WHO-GMP and ISO 9000:2015 certification. Our rigorous quality control ensures a consistent and reliable Resmetirom API supply, making us a top choice for Resmetirom API suppliers in India.
9. 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.
10. How Can I Place An Order For Resmetirom API?
To place an order for Resmetirom 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.
