Paclitaxel manufacturers

Paclitaxel is a highly potent antineoplastic agent. For B2B procurement, the purity level must typically be ≥99% as measured by HPLC. It is essential to verify the source of the precursor (e.g., semi-synthetic from Taxus baccata or via plant cell fermentation) to ensure consistency. Key specifications include residual solvents (meeting ICH Q3C guidelines), heavy metal limits (<20ppm), and a specific optical rotation that aligns with USP or EP pharmacopeia standards.

As a pharmaceutical active ingredient (API), the supplier must provide a Certificate of Analysis (COA) for every batch. Crucial regulatory documents include the Drug Master File (DMF) number, GMP (Good Manufacturing Practice) certification, and ideally a CEP (Certificate of Suitability) for the European market. Ensure the manufacturer is registered with the FDA if the destination is the United States.

Paclitaxel is light-sensitive and heat-sensitive. It must be stored in tight, light-resistant containers, typically double-layered PE bags inside aluminum foil bags or fiber drums. The recommended storage temperature is 2°C to 8°C (cold chain) or as specified by the manufacturer to prevent degradation. Temperature-controlled shipping and data loggers are highly recommended for international logistics.

Paclitaxel is primarily used as a raw material for injectable formulations (e.g., Paclitaxel Injection, Albumin-bound Paclitaxel) to treat ovarian, breast, and non-small cell lung cancer. It is also utilized in the production of drug-eluting stents for cardiovascular interventions. Buyers must ensure the particle size (micronization) meets their specific formulation requirements.

Always conduct third-party lab testing (e.g., SGS or Intertek) before final payment to verify purity and impurity profiles. Utilize Made-in-China.com's 'Audited Supplier' reports to verify the factory's physical existence and production capacity. Never rely solely on digital COAs; request pre-shipment samples from the actual production batch.

Focus on long-term supply stability rather than just the lowest price. Negotiate for tiered pricing based on annual volume and request price protection clauses against fluctuations in raw material (Taxus biomass) costs. Ensure the contract includes a clear refund/return policy if the batch fails to pass the buyer's internal Quality Control (QC) upon arrival.

Paclitaxel is often classified under HS Code 293299, but this can vary by region. It is a hazardous substance (Class 6.1 Toxic) in some jurisdictions; therefore, the supplier must provide a Material Safety Data Sheet (MSDS) and a Dangerous Goods Declaration. Ensure the freight forwarder is experienced in pharmaceutical cold chain logistics and customs clearance for controlled substances.

Use secure payment methods such as Letters of Credit (L/C) or Escrow services provided by Made-in-China.com to ensure funds are only released upon proof of shipment and document verification. Avoid untraceable wire transfers to personal accounts. Verify that the beneficiary bank account name matches the company name on the business license.