Pregabalin API is a premium-quality pharmaceutical-grade Active Pharmaceutical Ingredient (API) widely used in the formulation of antiepileptic, analgesic, and anxiolytic medications. Pregabalin is a gamma-aminobutyric acid (GABA) analogue that binds to the α2δ subunit of voltage-gated calcium channels, reducing the release of excitatory neurotransmitters. It is indicated for the treatment of neuropathic pain, diabetic peripheral neuropathy, postherpetic neuralgia, fibromyalgia, generalized anxiety disorder (in certain regions), and partial-onset seizures. Its exceptional purity, chemical stability, and consistent batch-to-batch quality make it ideal for pharmaceutical formulation development, analytical testing, quality control, stability studies, and authorized pharmaceutical research applications.
MEDIOCON INC is a trusted Pregabalin API manufacturer and bulk supplier in India, supplying premium-quality pharmaceutical ingredients to pharmaceutical companies, biotechnology organizations, contract manufacturing organizations (CMOs), formulation developers, research laboratories, and international distributors. Our GMP-compliant manufacturing facilities employ advanced production technologies and rigorous quality management systems to ensure superior purity, consistency, and compliance with international pharmaceutical standards.
Every batch of Pregabalin API manufactured by MEDIOCON INC undergoes comprehensive analytical testing using validated quality control methods. Critical quality parameters including identity, assay, impurity profile, moisture content, pH, melting point, specific rotation, residual solvents, particle size distribution, heavy metals, and stability are carefully evaluated before commercial release to ensure compliance with stringent pharmaceutical quality specifications.
Our Pregabalin API is available in USP, EP, BP, IP, and Pharmaceutical Grade, making it suitable for capsules, tablets, oral solutions, analytical testing, formulation development, quality control laboratories, stability studies, pharmaceutical process validation, and neurological pharmaceutical research. We also provide complete regulatory documentation, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and supporting regulatory documents, ensuring seamless procurement and regulatory compliance.
With a strong commitment to quality, innovation, and customer satisfaction, MEDIOCON INC has established itself as a dependable global supplier of pharmaceutical raw materials. Through secure packaging, competitive pricing, efficient logistics, and dedicated technical support, we ensure reliable worldwide delivery of premium-quality Pregabalin API.
If you are looking for a trusted Pregabalin API manufacturer, exporter, and bulk supplier, MEDIOCON INC provides pharmaceutical-grade ingredients backed by complete documentation, consistent quality, and timely worldwide supply.
| Parameter | Specification |
|---|---|
| Appearance | White to Off-White Crystalline Powder |
| Identification | IR / HPLC Complies |
| Assay (HPLC) | 99.0% – 101.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 6.0 – 7.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 0.5% |
| Water Content | NMT 0.5% |
| Specific Rotation | −10.5° to −12.5° (c = 1, Water) |
| Melting Point | 194°C – 198°C |
| Solubility | Freely Soluble in Water; Slightly Soluble in Methanol; Practically Insoluble in Ethanol and Chloroform |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Pregabalin API Manufacturer & Bulk Supplier in India | MEDIOCON INC (CAS 148553-50-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Pregabalin API Manufacturer & Bulk Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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