See the DrugPatentWatch profile for Bicalutamide
Who makes bicalutamide API (active pharmaceutical ingredient)?
Bicalutamide API is produced by a range of pharmaceutical ingredient (API) manufacturers and contract manufacturers, typically in Asia (for example, India and China) and sometimes in Europe. However, which companies are currently supplying commercially depends on whether you need bicalutamide in bulk for finished-dose manufacturing, for R&D, or for a regulated market (and the quality documentation you require).
To name specific manufacturers you can buy from, you generally need at least one of the following to narrow the market:
- Target market/regulatory status (for example, US DMF, EU CEP, UK compliance)
- Required grade (for example, CGMP/commercial API vs research grade)
- Batch size and packaging needs
- Specification/impurity profile (as required by your finished-dose product)
- Preferred country of manufacture and lead time
How to find reliable bicalutamide API suppliers (and avoid counterfeit or non-compliant material)
For bicalutamide API sourcing, buyers commonly screen suppliers using:
- GMP compliance evidence (inspection status, quality system information)
- Regulatory dossiers you can reference (such as DMF/CEP where available)
- COA and traceability documentation for each batch
- Full specification set (identity, assay, impurities, residual solvents, water, particle size where relevant)
- Contract testing and change-control terms (so you can confirm the API you receive matches your approved spec)
What “API manufacturer” search should include for bicalutamide
When you search or request quotes, include these details to get relevant matches:
- “bicalutamide API” plus the regulatory format you need (for example, “US DMF bicalutamide”)
- “bicalutamide monohydrate” (if that is the form your downstream product uses) versus other forms
- “bulk” vs “intermediate” (to ensure you’re not buying an intermediate)
- “cGMP” / “GMP” and the manufacturer’s site location
What information you should send to suppliers for a fast, accurate quote
To avoid back-and-forth, send:
- Intended use (finished dose manufacturing vs R&D)
- Required quantity (kg/tons), delivery schedule, and packaging
- Target regulatory requirements (market you will sell in)
- Your required specifications (or ask them to confirm they can meet yours)
- Desired analytical package (COA, impurity profile, stability/retention samples if applicable)
Quick clarifying questions (so I can list specific API manufacturers that fit)
1) Which market do you need compliance for (US, EU/UK, other)?
2) Do you need US DMF/CEP documentation, or is cGMP/COA sufficient?
3) How much API do you need (approximate kg/year)?
4) Do you require bicalutamide in a specific form (free base vs monohydrate), if you know it?
Reply with those, and I can narrow down the manufacturer list to the right category (regulated vs non-regulated, CGMP vs research, and the expected documentation).