Levomilnacipran SR Pellets Pellets Manufacturer in Maharashtra, India

Pharmaceutical-Grade Sustained Release Pellets for Oral Dosage Forms

Levomilnacipran SR Pellets Manufacturer Maharashtra India

Product Specifications

Product Name: Levomilnacipran SR Pellets
CAS Number: Available on request
Category: Pharmaceutical Pellets
Grade: IP / BP / EP / USP
Appearance: White to off-white crystalline powder
Standards: IP / BP / EP / USP compliant

Detailed Specifications

ParameterSpecification
AppearanceWhite to off-white crystalline powder
IdentificationIR & HPLC compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)2.0 – 4.0
Individual Impurity≤ 0.5%
Total Impurities≤ 1.5%

Levomilnacipran SR Pellets (CAS No: Available on request)

Pharmaceutical-Grade Sustained Release Pellets for Oral Dosage Forms

Levomilnacipran SR Pellets are pharmaceutical-grade sustained release pellets designed for capsule filling, minitablet compression, and multiparticulate oral dosage form manufacturing. These pellets provide predictable drug release profiles critical for bioequivalence and patient compliance.

Formulators sourcing Levomilnacipran SR Pellets evaluate pellet size distribution (500–1400 µm), drug content uniformity (RSD <2%), dissolution profile correlation (f2 >50 vs reference), and coating thickness consistency. Robust membrane integrity testing ensures reproducible in-vivo release performance.

Swapnroop Drugs and Pharmaceuticals manufactures Levomilnacipran SR Pellets from our WHO-GMP certified Aurangabad facility using Wurster fluid-bed coating technology. We supply dissolution-profiled batches with full regulatory documentation for ANDA/CTD dossier submissions.

Key Features

  • Controlled drug release profile (Sustained Release) with validated dissolution method
  • Pellet size distribution 500–1400 µm with <5% fines for capsule filling suitability
  • Drug content uniformity RSD <2% ensuring consistent dosing per capsule
  • WHO-GMP facility with Wurster coating technology and full process validation

Applications

  • Hard gelatin capsule filling for sustained release oral solid dosage forms
  • Multiparticulate tablet compression for modified-release dosage forms
  • Paediatric and geriatric formulations requiring flexible dose adjustment
  • Generic ANDA programs requiring dissolution-matched {rel_full.lower()} profiles

Why Choose Swapnroop for Levomilnacipran SR Pellets?

  • WHO-GMP certified Aurangabad facility with Wurster coating and characterisation equipment
  • Full dissolution profiling data in multiple pH media (1.2, 4.5, 6.8) for bioequivalence support
  • Consistent pellet batches with 24-month stability from ICH-compliant storage conditions
  • DMF-grade documentation package for USFDA, EMA, and CDSCO regulated submissions

Packaging & Supply

Levomilnacipran SR Pellets are supplied in double-layer LDPE bags within amber HDPE containers (1 kg, 5 kg, 10 kg) with nitrogen purge and desiccant sachets to protect the coating integrity and drug potency during storage and international transit.

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Frequently Asked Questions about Levomilnacipran SR Pellets

What is the drug release profile of Levomilnacipran SR Pellets?

Levomilnacipran SR Pellets are designed to provide a sustained release profile with dissolution tested in USP Apparatus 1/2 at multiple pH media. Actual dissolution profile data and f2 comparison data available on request.

What regulatory documentation is supplied with Levomilnacipran SR Pellets?

Full CoA, dissolution profile report, MSDS, drug content uniformity data, coating weight data, and regulatory support for ANDA/CTD dossier submissions including DMF referencing.

What is the MOQ and lead time for Levomilnacipran SR Pellets?

Minimum order is 1 kg for R&D sampling and 5 kg for development batches. Standard commercial lead time is 3–4 weeks from our Aurangabad, Maharashtra facility.

Are Levomilnacipran SR Pellets WHO-GMP certified?

Yes. All pellet batches are manufactured at our WHO-GMP certified facility in MIDC Shendra, Aurangabad, with validated Wurster coating process and full traceability documentation.

Levomilnacipran SR Pellets Bulk Supplier in Maharashtra, India

Swapnroop Drugs and Pharmaceuticals is a trusted Levomilnacipran SR Pellets manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Levomilnacipran SR Pellets with full dissolution profiling, competitive pricing, and complete documentation for capsule fill and multiparticulate development programs.

Levomilnacipran SR Pellets Exporter from India – Regulatory Support

As a Levomilnacipran SR Pellets supplier from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, CoA, dissolution data, and regulatory filing assistance. Contact us for pricing, samples, and technical data.