Skeletal muscle relaxant API
Metaxalone API
Manufactured in-house at our Saykha GIDC plant in IP, BP, USP and EP grades — supplied with batch CoA as standard and DMF support for regulated filings.
Overview
Metaxalone is a centrally acting skeletal muscle relaxant used in oral formulations for the relief of discomfort from acute, painful musculoskeletal conditions such as strains and sprains. It sits in a mature generic segment where formulators run repeat campaigns, so a consistent impurity profile and dependable delivery matter as much as headline price when choosing a source.
Apex Pharma API has manufactured Metaxalone since 2015 on a single established route, which keeps the impurity profile steady from campaign to campaign. You buy directly from the plant that makes it, with the QC team that released the batch on hand to answer your questions.
Specifications
| Product name | Metaxalone (bulk active pharmaceutical ingredient) |
|---|---|
| CAS number | 1665-48-1 |
| Molecular formula | C12H15NO3 |
| Molecular weight | 221.25 |
| Grades available | IP · BP · USP · EP |
| Appearance | White to off-white crystalline powder |
| Assay | Per applicable pharmacopoeial monograph (grade-specific) |
| Packaging | 1 kg / 5 kg / 25 kg — HDPE drum with double LDPE liner; other configurations on request |
| Storage | Store in a tightly closed container, protected from light and moisture, at controlled room temperature |
| Supply capacity | Trial quantities to repeat commercial volumes — confirmed at quotation |
Full specification sheet and method of analysis issued with the quotation. Packaging and storage confirmed per destination market.
Applications
Oral solid dosage forms for the relief of acute painful musculoskeletal conditions.
Tablets used alongside rest and physical therapy in strains and sprains.
Fixed-dose combinations where a stable impurity profile is required across batches.
Reference-standard grade material for formulators building ANDA and generic filings.
Regulatory & documentation
Everything your QA and regulatory teams need to open a file on us, issued at quotation stage rather than after the order.
Metaxalone API — buyer questions
What is the minimum order quantity for Metaxalone API?
We ship from trial quantities upward. Your commercial MOQ is set against the grade and pack size you need and is confirmed at quotation rather than fixed across all buyers.
Do you provide a sample and CoA before I order?
Yes. Evaluation samples go out with the batch CoA so your QC team can check the material against your own specification before a PO is raised.
What lead time should I plan for?
Stocked grades leave within days of a confirmed order. For campaign volumes we schedule production and give you a firm despatch date before you commit.
Can you support a DMF or dossier filing?
DMF support and open-part documentation are available on request. Tell us the destination market and we will confirm the documents we can supply.
Related products
Read: Metaxalone uses and applications →Get a Metaxalone API quote
Grade, quantity, destination — we will come back with price, lead time and documentation.