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Skeletal muscle relaxant API

Metaxalone API Manufacturer & Supplier in India

CAS 1665-48-1 C12H15NO3 M.W. 221.25

Apex Pharma API is a Metaxalone API manufacturer and supplier based in India, producing bulk active pharmaceutical ingredient for pharmaceutical formulation companies and distributors. Metaxalone is an oxazolidinone-derivative muscle relaxant used in the formulation of medicines for musculoskeletal pain, and we manufacture it in-house at our Saykha GIDC plant to the documentation and quality standards B2B buyers rely on when qualifying a new supplier.

Metaxalone API — bulk active pharmaceutical ingredient

What is Metaxalone API?

Metaxalone (CAS No. 1665-48-1) is an oxazolidinone-derivative compound formulated as a skeletal muscle relaxant, historically marketed under the brand name Skelaxin. Its precise mechanism of action has not been definitively established in the pharmacological literature — unlike many muscle relaxants, it does not appear to act directly on striated muscle fibres, the neuromuscular junction or motor nerve conduction. Current understanding attributes its clinical effect to general central nervous system depression rather than a peripheral action, which is a meaningful technical distinction for formulators comparing it against other agents in the same category.

Metaxalone is generally used as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions such as strains and sprains. Apex Pharma API manufactures and supplies the API itself — the bulk active ingredient — not the finished branded or generic product.

Metaxalone API manufacturing at Apex Pharma API

We have manufactured Metaxalone in-house since 2015 at our Saykha GIDC plant in Bharuch, on a single established route that keeps the impurity profile steady from campaign to campaign. Production runs in a 4 KL stainless-steel reactor, so we supply from evaluation samples through to repeat commercial volumes, and you buy directly from the plant that makes it with the QC team that released the batch on hand. Our complete product range and general sourcing process are covered on our API manufacturing page.

Applications and uses

Metaxalone API is used in formulations intended to relieve musculoskeletal pain and muscle spasm associated with acute strains and sprains, typically as an adjunct to rest and physical therapy rather than as a standalone intervention. Clinical literature notes a relatively low reported incidence of side effects compared with some other agents in the muscle-relaxant category, which is part of why the molecule maintains steady formulation demand despite a smaller supplier base than more widely produced muscle relaxants. This is general pharmacological context for buyer understanding, not a claim about specific finished products manufactured by our customers.

Industries and customers we serve

Metaxalone API from Apex Pharma API is supplied to pharmaceutical formulation manufacturers producing solid oral dosage forms, to distributors supplying API onward within their own network, and to R&D and generic-development teams needing API for formulation trials ahead of scale-up. Our full buyer-segment breakdown is on the API manufacturing companies in India page.

Why choose Apex Pharma API for Metaxalone API

  • GMP- and GLP-certified manufacturing (Gujarat FDCA), with an ISO 9001:2015 quality management system and MSME ZED Bronze certification.
  • Manufactured in-house since 2015 on a single established route at our Saykha GIDC plant, so the impurity profile is consistent campaign to campaign.
  • A batch-wise Certificate of Analysis as standard, with MSDS, specification sheet and method of analysis available, and DMF documentation on request.
  • Manufacturer pricing, quoted directly — supply from trial quantities through to repeat commercial volumes, with evaluation samples available before a bulk order.

Product & technical information

Product name Metaxalone (bulk active pharmaceutical ingredient)
CAS number 1665-48-1
Drug class Oxazolidinone derivative / muscle relaxant
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.

Quality & compliance

Manufactured under GMP and GLP certificates from the Gujarat FDCA, with an ISO 9001:2015 quality management system and MSME ZED Bronze certification. A batch-wise Certificate of Analysis is issued as standard, and everything your QA and regulatory teams need is available at quotation stage.

GMP MANUFACTUREDGLP TESTEDDMF ON REQUESTCoA PER BATCHMSDSMETHOD OF ANALYSIS
See the full quality & certifications detail →

Metaxalone API — frequently asked questions

What is Metaxalone API used for?

It is formulated into muscle relaxant medicines used to relieve discomfort from acute, painful musculoskeletal conditions such as strains and sprains, typically alongside rest and physical therapy.

What is the CAS number for Metaxalone?

1665-48-1. Metaxalone is an oxazolidinone-derivative skeletal muscle relaxant with the molecular formula C12H15NO3.

How does Metaxalone work?

Its precise mechanism has not been fully established in the literature, but its clinical effect is attributed to general central nervous system depression rather than any direct action on muscle fibres, the motor end plate or nerve conduction.

What grades of Metaxalone API do you supply?

IP, BP, USP and EP grades, against the applicable pharmacopoeial monograph.

Is a Certificate of Analysis provided with each batch?

Yes. A batch-wise Certificate of Analysis is issued as standard with every despatch, alongside the MSDS, specification sheet and method of analysis.

Is a DMF available for Metaxalone?

DMF documentation is available on request — tell us your destination market and filing type and we will confirm what we can provide.

Does Apex Pharma API export Metaxalone?

Yes. We supply non-regulated export markets, with export documentation prepared in-house at our Bharuch plant. Share your destination and we will confirm what is required before you order.

What is the minimum order quantity?

We supply from trial quantities upward. The commercial MOQ is confirmed against your grade and packaging requirement at quotation — it is not a fixed number across all buyers.

Can I request a sample before a bulk order?

Yes. Evaluation samples go out with a batch CoA so your QC team can check the material against your own specification before a PO is raised.

Related products

Read: Metaxalone uses and applications →
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