Resmetirom API Manufacturers and Suppliers in India
Resmetirom is a selective thyroid hormone receptor-beta (THR-beta) agonist, CAS 920509-32-6, molecular formula C17H12Cl2N6O4, molecular weight 435.22 g/mol. It is the first molecule approved by the USFDA (March 2024) for noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis, and demand for the API has followed that approval. It is supplied as a white to off-white powder. Bio-Synth manufactures Resmetirom API with all intermediates in-house at its Balanagar plant in Hyderabad.
Product Description
Product Description
Product Description
Product 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 formula: C17H12Cl2N6O4
Molecular weight: 435.22 g/mol
Category: Thyroid hormone receptor (THR)-beta agonist
Therapeutic use: Noncirrhotic NASH with moderate to advanced fibrosis
Form: Powder
Color: White to off-white
Solubility: Slightly soluble in acetic acid; sparingly soluble in DMSO; practically insoluble in water
Packing: As per requirement
Resmetirom API Specification
The published specification for Bio-Synth’s Resmetirom API:
- ☐ Assay by HPLC: not less than 98.0% and not more than 102.0%
- ☐ Total impurities: not more than 0.5%
- ☐ Any unspecified impurity: not more than 0.1%
Each batch ships with a Certificate of Analysis covering description, identification by IR and HPLC, assay, related substances, residual solvents by GC against ICH Q3C class limits, loss on drying and residue on ignition. A 0.5% total-impurity cap is a tight limit for a molecule of this complexity – ask for the full impurity table and the named specified impurities when you request the specification sheet.
Resmetirom is practically insoluble in water, so dissolution behaviour in formulation is driven by particle properties. Agree on the particle size distribution you need at the inquiry stage.
Bio-Synth offers Resmetirom with an assay range of 98%-102% w/w basis, total impurities of not more than 0.5% and LOD not more than 0.5% with a monthly capacity of 1MT.
Resmetirom API Manufacturers in India
Bio-Synth – Biochemical and Synthetic Products Private Limited – has manufactured active pharmaceutical ingredients at Balanagar, Hyderabad since 1943, under manufacturing licence 118/HD/AP/96/B/R.
Resmetirom is a new-generation molecule, and for a recently approved API the supplier question is really a route-ownership question. Bio-Synth synthesises all Resmetirom intermediates in-house, so every stage of the route sits under one quality system. The impurity profile is controlled from the first stage rather than inherited from an intermediate vendor, and a change to any step moves through one change-control system. The reaction capabilities behind the route are published separately. Manufacturing follows ICH Q7 principles – process validation, change control, validated cleaning between campaigns, complete batch records.
Resmetirom API Suppliers in India
Pack size is agreed per order. Standard configuration for a solid API of this class is HDPE drums with double liners, tamper-evident sealing, and labelling with product name, batch number, manufacturing and retest dates and net quantity. The document set that travels with a consignment: Certificate of Analysis, safety data sheet, and a Certificate of Pharmaceutical Product where the destination requires one.
A first order normally runs: specification and representative CoA, then a sample for your own identity, assay and impurity checks, then a quotation with Incoterms, lead time and minimum order quantity in writing, then vendor qualification.
Resmetirom API Price in India
Resmetirom is quoted per kilogram against a specific specification and volume. For a recently approved molecule, pricing is driven harder by route efficiency and campaign scheduling than it is for older APIs. Grade and specification, order volume, packing configuration and lead time set the number; in-house intermediates keep the cost base under one roof.
Send your specification, quantity and destination market and you will get a firm quotation rather than a range.
Quality and Compliance
The Balanagar site holds ISO 9001:2015 certification issued by DNV under UKAS accreditation, certificate number 156792-2014-AQ-IND-UKAS, initially certified in August 2002, scoped to “Development, manufacture and sale of active pharmaceutical ingredients (APIs), drug intermediates, biological products & liver injectable”. Manufacturing follows ICH Q7 principles, with ICH Q3A and Q3C governing impurity and residual solvent limits and ALCOA+ applied to laboratory and batch records. More sits on the quality management system page.
The site also holds a WHO-GMP certificate issued by the Drugs Control Administration, Government of Telangana – L.Dis.No. 150458/TS/2024 dated 06/06/2024, valid until 05/06/2027. It is a facility-level certificate issued under the export scheme, covering the products named in its joint inspection report. Ask which certificate names which product and we will send the annexure.
How Resmetirom Works and Where It Is Used
Resmetirom mimics triiodothyronine (T3) selectively at the thyroid hormone receptor beta, the subtype that dominates in the liver. Activating THR-beta stimulates hepatic fatty acid oxidation and lipid clearance, which reduces liver fat, improves lipid profiles – LDL-C, triglycerides, non-HDL-C – and can modestly improve fibrosis. Because the action is liver-directed rather than systemic, it avoids the cardiac and bone effects of non-selective thyroid hormone activity.
The approved indication is noncirrhotic NASH with moderate to advanced fibrosis (stages F2 to F3), in conjunction with diet and exercise. For formulators this is a once-daily oral solid dose molecule with poor aqueous solubility – particle engineering matters.
Resmetirom API FAQs
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1. Who is the manufacturer of Resmetirom in India?
Several Indian API makers have taken it up since the 2024 USFDA approval of the originator product. Bio-Synth manufactures Resmetirom API with all intermediates in-house at Balanagar, Hyderabad, against a published specification with assay 98.0-102.0% and total impurities not more than 0.5%.
2. What is Resmetirom API used for?
It is the active ingredient in therapy for noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis, taken with diet and exercise. It is the first molecule approved for that indication.
3. What is the CAS number of Resmetirom?
920509-32-6. Molecular formula C17H12Cl2N6O4, molecular weight 435.22 g/mol.
4. What is the price of Resmetirom API in India?
Quoted per kilogram against your specification and volume, not sold at a list price. For a recently approved molecule, route efficiency and campaign scheduling move the figure more than they do for older APIs.
5. What documentation ships with an order?
Certificate of Analysis, safety data sheet, and a Certificate of Pharmaceutical Product where the destination requires one. Specification sheet and a representative CoA are available before you order.
6. Which certificates cover Resmetirom specifically?
The site holds ISO 9001:2015 (certificate 156792-2014-AQ-IND-UKAS) covering development, manufacture and sale of APIs and intermediates, and a WHO-GMP certificate held at facility level for the products named in its joint inspection report. Ask for the annexure – a certificate covers what it names.
Request a Quotation
Send your specification, required quantity, pack size and destination market. You will get the specification sheet, a representative Certificate of Analysis and a quotation with Incoterms and lead time. Contact Bio-Synth with the details.
Resmetirom sits in the full API product portfolio.
