Mebeverine SR Pellets Manufacturer India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Mebeverine  SR Pellets (CAS No: 2753-45-9) — Sustained Release Multiparticulates

Mebeverine HCl SR Pellets are sustained-release pharmaceutical pellets manufactured from Mebeverine Hydrochloride (C₂₅H₃₆ClNO₅, MW ≈466.0), a musculotropic antispasmodic used in gastrointestinal smooth-muscle-spasm conditions such as irritable bowel syndrome (IBS). Swapnroop Drugs and Pharmaceuticals manufactures Mebeverine HCl SR Pellets at its WHO-GMP certified Aurangabad, Maharashtra facility, supplying pharmaceutical formulators across India and export markets in 25+ countries.

Formulation Approach
Mebeverine HCl SR pellets are produced by layering the drug onto an inert or drug-crystal core followed by a rate-controlling functional polymer coat, calibrated to deliver an extended-release profile suited to once- or twice-daily antispasmodic capsule formulations.

Key Features

  • Sustained-release multiparticulate antispasmodic formulation
  • Drug substance is the hydrochloride salt of Mebeverine, a smooth-muscle relaxant
  • Suitable for hard-gelatin capsule filling and multiparticulate tablet compression
  • WHO-GMP manufactured with full batch documentation

Applications

  • Irritable Bowel Syndrome (IBS) and GI smooth-muscle spasm formulations
  • Sustained-release antispasmodic capsule development
  • Generic ANDA/CTD dossier programs requiring dissolution-matched SR profiles

Why Choose Swapnroop for Mebeverine SR Pellets?

  • WHO-GMP certified Aurangabad facility with drug-layering and functional-coating capability
  • Full CoA, MSDS, and DMF-grade documentation for USFDA, EMA, and CDSCO submissions
  • Export experience across 40+ countries

FAQs

  • What condition is Mebeverine HCl typically used for? It is a musculotropic antispasmodic most commonly used for IBS-related GI smooth-muscle spasm.
  • Is a specific mesh size available? Confirm current SDP offering — mesh/particle size is set per formulation requirement.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.1%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 0.5%
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