Nalbuphine Injection Suppliers & Bulk Manufacturers
Available Forms: Injectable (IM, IV)
Available Strengths: 10 mg/mL, 20 mg/mL
Reference Brands: Generic formulations marketed under different names
Category: Analgesic
Nalbuphine injectable activates kappa-opioid receptors and blocks mu-opioid receptors, providing analgesia with a ceiling effect on respiratory depression. It effectively relieves moderate to severe pain, offering rapid onset, fewer respiratory risks, and suitability for opioid-sensitive patients, making it a safer option for hospital and clinical pain management. Nalbuphine Injection is available in Injectable (IM, IV) and strengths such as 10 mg/mL, 20 mg/mL. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Nalbuphine Injection is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Nalbuphine Injection can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
Product Description:
Nalbuphine injectable is approved in the US and EU for managing moderate to severe pain, particularly in hospitals. In the US, brands like Nalbuphine Hydrochloride are regulated by the FDA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the EU, approval by EMA requires comprehensive dossiers, clinical data, and pharmacovigilance plans. Due to its ceiling effect on respiratory depression, nalbuphine is favored for safe analgesia in clinical settings. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We facilitate seamless market access for nalbuphine injections, ensuring adherence to European and US standards for safe, effective pain management.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Nalbuphine is used for the relief of moderate to severe pain and is often given before or after surgery. It works as an opioid analgesic by reducing how the brain senses pain.
Nalbuphine is made from nalbuphine hydrochloride, a semi-synthetic opioid derived from thebaine, which is an opiate found in the poppy plant.
The commonly known trade name is Nubain.
Nalbuphine is manufactured by several companies worldwide, with Nubain originally marketed by Endo Pharmaceuticals. Many generic manufacturers also produce it.
The generic name is nalbuphine hydrochloride.
The widely known brand name is Nubain.
Nalbuphine is manufactured in multiple countries, including India, the USA, and several EU regions, by various pharmaceutical companies producing both branded and generic versions.
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