All Methadone HCl products (Powder USP, 10mg/ml Oral Solution, and 1mg/ml Oral Concentrate) comply with USP/EP monographs, DEA Schedule II requirements, and cGMP guidelines. We provide full DMF (Drug Master File) access, Certificates of Analysis (COA), and stability data for FDA/EMA submissions.

Yes, we offer Methadone HCl Powder USP in bulk (minimum 25kg drums) suitable for compression into tablets or encapsulation. Purity ≥99.0%, with low impurity profiles (e.g., ≤0.1% E-isomer). Custom milling and particle size distribution available upon request.

Our 10mg/ml Oral Solution and 1mg/ml Oral Concentrate meet USP dissolution and assay requirements (95–105% potency), with pH 3.5–4.5, microbial limits <10 CFU/ml, and no preservatives in select variants. Both are stability-tested for 24–36 months under ICH conditions.

We specialize in 12–24 month offtake agreements with fixed or indexed pricing (tied to CPI or raw material indices), volume commitments, and dual-sourcing guarantees to ensure uninterrupted supply for OUD programs and generic production.

All shipments include DEA Form 222 compatibility, tamper-evident packaging, and serialized tracking. We hold valid DEA registrations for import/export and provide audit-ready documentation, including chain-of-custody logs and diversion control plans.

Technical samples (100g powder or 500ml liquid) are available within 5–7 business days post-qualification. Include your NDA/ANDA details in the inquiry for expedited regulatory review and accompanying COA/SDS.

Options include 1L amber glass bottles, 5L HDPE jerry cans, or 20L IBC totes, all with child-resistant closures and nitrogen purging for extended shelf life. Custom labeling for private-label programs supported.

Our technical team offers support for bioequivalence studies, flavor masking in oral solutions, and dossier compilation (eCTD format). We also facilitate supplier audits and provide impurity method validation data.

Manufactured in FDA-inspected, ISO 9001/14001-certified facilities in Europe and India, with segregated production lines for controlled substances. Full traceability from raw narcotic precursors to finished API, including third-party testing by labs like SGS or Eurofins.

Submit your RFI via the contact form with target volumes, specs, and regulatory needs. Our B2B team responds within 24 hours with a preliminary quote, lead time (typically 4–8 weeks for first order), and qualification package (including site master file excerpts).