Tramadol Hydrochloride (HCl) API – GMP-Certified
Tramadol HCl is a centrally-acting analgesic used for the management of moderate to severe pain. The chemical name for Tramadol HCl is (±)cis-2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol hydrochloride. It appears as a white, crystalline, and odorless powder that is readily soluble in water and ethanol, making it suitable for various pharmaceutical formulations.
Molecular Formula: C16H25NO2•HCl
Molecular Weight: 299.84 g/mol
CAS. No: 36282-47-0
Product Description
Vonage Pharma sells Tramadol Hydrochloride narcotic API, a high purity opioid analgesic active pharmaceutical ingredient (API) for use in the production of pain-relieving medicines. Vonage Pharma’s Tramadol HCl API is produced in GMP-certified facilities recognized for meeting USP/EP/BP pharmacopoeial standards. The proper purity and quality of Vonage Pharma’s Tramadol HCl API will provide the required effectiveness and safety profile in pharmaceutical formulations to relieve pain from moderate to severe pain.
Key Features
✔ 99.5 %+ HPLC purity
✔ White crystalline powder, freely soluble in water/ethanol
✔ Strict impurity control (ICH Q3D compliant)
✔ DMF/CEP filed for streamlined regulatory approvals
✔ BSE/TSE-free, residual solvent-free
Applications
Tramadol HCl API is used in:
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Immediate-release tablets (50–100 mg doses)
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Extended-release formulations (chronic pain management)
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Combination drugs (e.g., Tramadol + Acetaminophen)
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Hospital injectables (lyophilized powder for solution)
Technical Specifications
| Parameter | Specification |
|---|---|
| CAS No. | 36282-47-0 |
| Molecular Formula | C₁₆H₂₅NO₂·HCl |
| Melting Point | 180–184°C |
| Loss on Drying | ≤0.5% |
| Heavy Metals | ≤10 ppm |
Why Partner With Vonage Pharma?
✅ End-to-End Compliance: DMF, GMP-approved manufacturing with full regulatory support.
✅ Global Supply Chain: Reliable bulk quantities (1kg–500kg) with cold-chain logistics.
✅ Custom Solutions: Tailored particle size, polymorphism, and packaging (e.g., aluminum pouches, drum packaging).
✅ R&D Collaboration: Technical dossiers and formulation support for ANDA/NDA filings.
Market Demand
- One study projects the market for the Tramadol drug to be $2.35 billion in 2024, with a CAGR of 4.53% until 2034 (Tramadol Drug Market Overview).
- Another report suggested a CAGR of 6.8% from 2024 to 2030 (Tramadol Drug Market Report).
Order Tramadol HCl API
Available in GMP grades. Contact us for samples and details.
FAQ
What are the packaging requirements for Tramadol HCl?
Tramadol HCl has to be packaged in containers that are tamper-evident and child-resistant, have a Medication Guide, and must have a 'do not crush ER' label.
What are the storage requirements for Tramadol HCl?
Tramadol HCl should be kept below 20-25 °C with restricted access to DEA compliant, regulated areas, and protected from moisture and light.
What are the regulatory requirements for manufacturing Tramadol HCl?
Regulatory requirements to produce Tramadol HCl involves fulfilling all of the Tramadol HCl Schedule IV controls, Opioid Analgesic REMS, disseminating a Medication Guide, and monitoring postmarketing adverse event.
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