Pharmaceutical-Grade Direct Compression Granules for Solid Dosage Forms
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Dapoxetine DC Granules are pharmaceutical-grade direct compression granules engineered for high-throughput tablet manufacturing without wet granulation. These granules provide excellent flowability, compressibility, and content uniformity critical for regulated solid dosage form production.
Formulators sourcing Dapoxetine DC Granules evaluate particle size distribution (D50, D90), bulk/tapped density ratio, angle of repose, and moisture content for press performance. Batch-to-batch consistency in compressibility index (Carr's Index <20%) ensures reliable tableting across different press configurations.
Swapnroop Drugs and Pharmaceuticals manufactures Dapoxetine DC Granules from our WHO-GMP certified Aurangabad facility. We supply controlled particle size batches with full granule characterisation data, CoA, and regulatory documentation support for ANDA/CTD dossier submissions.
Dapoxetine DC Granules are supplied in double-layer HDPE bags within fibre drums (10 kg, 25 kg) with desiccant sachets to maintain flowability and prevent moisture uptake during storage and transit.
Get Bulk QuoteDapoxetine DC Granules are available with D50 in the 100–300 µm range, optimised for direct compression. Customised particle size distributions can be discussed for specific press and formulation requirements.
We provide full CoA, MSDS, particle size analysis report, bulk/tapped density data, moisture content certificate, and regulatory dossier support for ANDA/CTD submissions.
Minimum order is 5 kg for development batches and 25 kg for commercial supply. Standard lead time is 2–3 weeks from our Aurangabad, Maharashtra facility.
Yes. All granule batches are manufactured at our WHO-GMP certified facility in MIDC Shendra, Aurangabad, with full traceability and quality documentation for regulated market submissions.
Swapnroop Drugs and Pharmaceuticals is a trusted Dapoxetine DC Granules manufacturer and bulk supplier in Aurangabad, Maharashtra, supplying pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Dapoxetine DC Granules with full characterisation data, competitive pricing, and complete documentation for solid dosage form development and commercial production.
As a Dapoxetine DC Granules supplier from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, CoA, particle size analysis, and regulatory filing assistance for USFDA and EU submissions. Contact us for pricing, samples, and technical data.