Neurological & CNS

MetaxaloneThird Party Manufacturing in India

Looking to get Metaxalone manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
1665-48-1
Drug Class
Skeletal muscle relaxant
Molecular Formula
C₁₂H₁₅NO₃
Molecular Weight
221.25 g/mol
Grade Standards
IP, BP, USP
Therapeutic Category
Neurological & CNS
MOQ
1,000 tablets per batch
Dosage Forms
Tablet

Mechanism of Action

Metaxalone is a centrally acting skeletal muscle relaxant whose precise mechanism is not fully understood but is believed to involve depression of the central nervous system at the level of the brainstem and spinal cord. It does not act directly on skeletal muscle at the neuromuscular junction or on the muscle fibre itself. Instead, Metaxalone is thought to exert its effects by inhibiting polysynaptic reflexes in the spinal cord, reducing the transmission of nerve impulses that mediate muscle tone and spasm. This central depressant activity decreases the frequency and intensity of muscle contractions without impairing voluntary motor function at therapeutic doses. The drug also has sedative properties that contribute to its clinical effectiveness, as muscle spasm is often exacerbated by anxiety, stress, and pain perception. By reducing both the neural drive to muscles and the conscious perception of discomfort, Metaxalone helps break the pain-spasm-pain cycle that characterises acute musculoskeletal conditions. Unlike benzodiazepines, Metaxalone does not act on GABA-A receptors and has a different safety profile with lower potential for physical dependence. It is rapidly absorbed after oral administration, reaches peak plasma concentrations within three hours, and is extensively metabolised in the liver by cytochrome P450 enzymes, primarily CYP1A2 and CYP2D6.

Therapeutic Uses & Indications

Therapeutic Uses

Metaxalone is prescribed for the treatment of:

  • Acute musculoskeletal pain associated with muscle spasm: Provides relief from painful muscle spasms due to strains, sprains, and other acute soft tissue injuries.
  • Low back pain: Effective as an adjunct to rest and physical therapy for acute mechanical low back pain with muscle spasm.
  • Whiplash and cervical sprain: Reduces neck muscle spasm and associated pain following hyperextension-flexion injuries.
  • Fibromyalgia-related muscle tension: Used adjunctively to manage painful muscle tightness in fibromyalgia patients.
  • Post-surgical muscle spasm: Helps manage involuntary muscle contraction following orthopaedic or spinal surgery.

Why Manufacturers Choose Metaxalone

Metaxalone is one of the most prescribed skeletal muscle relaxants in the United States and enjoys growing acceptance in international markets. It is available in a single 800 mg tablet strength, simplifying production and inventory management. The drug has a more favourable sedation profile compared to older muscle relaxants like cyclobenzaprine and carisoprodol, giving it a competitive edge. API is readily available from multiple Indian manufacturers, and the tablet formulation uses standard direct compression or wet granulation methods. The molecule is well-suited for both domestic Indian marketing and high-value export to the US (USP standards) and other regulated markets. This makes Metaxalone one of the most sought-after molecules for third party manufacturing in India, with consistent demand from PCD franchise operators and export-oriented companies.

Dosage Forms We Manufacture

Tablet
800mg

Frequently Asked Questions

What is the minimum order quantity for Metaxalone?
Minimum order quantity for Metaxalone is 1,000 tablets per batch. Please contact us for bulk pricing and custom quantities.
What dosage forms of Metaxalone can you manufacture?
We manufacture Metaxalone as: Tablet (800mg).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Metaxalone for export?
Yes. We provide export-ready Metaxalone formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Metaxalone?
We manufacture Metaxalone to IP, BP, USP pharmacopoeial standards.
Third Party Manufacturing

Get Metaxalone made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • MOQ from 1,000 tablets per batch
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Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

Blister pack (Alu-Alu), Strip pack, HDPE bottle. Packaging customized to client brand guidelines.

Start Manufacturing Metaxalone Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Metaxalone across all dosage forms. PCD franchise and export orders welcome.

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