MEDIOCON INC is a trusted global manufacturer and supplier of Nalbuphine Hydrochloride API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, sterile injectable formulation development, analytical testing, quality control, stability studies, and research applications. Every batch is manufactured under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.
Nalbuphine Hydrochloride is a synthetic opioid analgesic with mixed kappa-opioid receptor agonist and mu-opioid receptor antagonist activity. It is widely used in pharmaceutical formulations for the management of moderate to severe pain, perioperative analgesia, postoperative pain control, obstetric analgesia, and anesthesia adjunct therapy. Nalbuphine Hydrochloride provides effective pain relief with a lower incidence of respiratory depression and reduced abuse potential compared to many full opioid agonists. It is also extensively utilized in pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.
MEDIOCON INC supplies premium-quality Nalbuphine Hydrochloride API to pharmaceutical manufacturers, injectable formulation companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), universities, research institutes, and analytical laboratories worldwide. Comprehensive documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and regulatory support documents is available upon request.
| Parameter | Specification |
|---|---|
| Appearance | White to Off-White Crystalline Powder |
| Identification | IR, UV & HPLC Compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.50% |
| Residue on Ignition | NMT 0.10% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.0 – 6.5 |
| Individual Impurity | NMT 0.50% |
| Total Impurities | NMT 1.00% |
| Water Content | NMT 0.50% |
| Melting Point | 245°C – 250°C |
| Solubility | Freely soluble in water; slightly soluble in methanol and ethanol |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Nalbuphine Hydrochloride API Manufacturer & Supplier (CAS 23277-43-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Nalbuphine Hydrochloride API Manufacturer & Supplier 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.
Export Markets
Quality & Compliance