Frequently Asked Questions

Generic Specialty is an independent pharmaceutical API sourcing and distribution partner. We connect drug manufacturers, CMOs, and compounding pharmacies with GMP-certified API manufacturers globally — and provide the complete regulatory documentation to go with every supply.

No. We are a sourcing and distribution partner, not a manufacturer. This is a deliberate advantage: we are not tied to a single facility or proprietary portfolio. We can source and compare the best-qualified, most cost-competitive options globally for your specific API and regulatory needs.

Our clients include pharmaceutical manufacturers, contract manufacturing organisations (CMOs), specialty generic developers, compounding pharmacies, and academic/research institutions — primarily in Canada, the USA, Europe, and emerging markets.

Yes — Generic Specialty is part of the Burrard Pharma group. Burrard Pharma is a Vancouver-based CDMO specialising in drug formulation, technology transfer, and regulatory services. Generic Specialty focuses specifically on API sourcing and supply.

A Complete Source Quote is Generic Specialty's standard inquiry response. Unlike a typical broker who sends just a price, we deliver a complete package: Certificate of Analysis, USDMF/CEP status, impurity profile (ICH Q3A), stability data summary, GMP certificate, manufacturer details, pricing, MOQ, lead time, and country of origin — all in one response within 24 business hours.

Use the inquiry form on our homepage or molecule-specific pages (e.g. Semaglutide, Tirzepatide). You can also email [email protected] directly. Include molecule name, quantity, grade, and target regulatory market.

Yes — our inquiry form supports file uploads (PDF, DOC, XLS, up to 10 MB). You can attach existing CoA specs, target impurity limits, required polymorph/particle size data, or stability protocol requirements.

We commit to responding to all Complete Source Quote requests within 24 business hours. For standard molecules in our catalog, turnaround is typically faster. Complex or unusual molecules may require additional sourcing time, which we will communicate upfront.

A US Drug Master File (USDMF) is a confidential submission to the FDA containing detailed information about the API manufacturing process, facility, and controls. An active USDMF on file allows your ANDA or NDA to reference it during FDA review — reducing your regulatory burden and speeding up approval timelines.

A CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) is issued by EDQM and confirms that an API's production meets Ph.Eur. quality standards. It is often required for EMA marketing authorisation applications in Europe. We confirm CEP status for each API at the quote stage.

Yes — we only source from GMP-certified manufacturers. GMP certificates from relevant regulatory authorities (USFDA, WHO-GMP, EU GMP, etc.) are included in every Complete Source Quote. Audit reports are available for qualified buyers under NDA.

We are fully aligned with current FDA and EMA nitrosamine guidance. APIs in high-risk categories (sartans, metformin, ranitidine analogues) are sourced from manufacturers with documented nitrosamine risk assessments and confirmatory testing per ICH M7. Results are included in the dossier.

Generic Specialty does not source DEA Schedule I or Schedule II controlled substances. Enquiries for Schedule III–V substances are assessed case-by-case depending on jurisdiction and documentation requirements. Please contact us directly to discuss.

Yes — GLP-1 APIs including Semaglutide (USDMF on file/active) and Tirzepatide (USDMF available) are among our highest-priority molecules. Both are available with complete regulatory dossiers and competitive lead times.

Yes. Our online catalog shows frequently requested molecules, but we can source virtually any GMP pharmaceutical API. Submit an inquiry with the molecule name, quantity, and regulatory requirements and we will confirm availability and documentation status within 24 hours.

Yes — we supply HPAPI including oncology molecules such as Paclitaxel (OEB4/5) and Docetaxel. Full containment documentation (OEB classification, handling protocols, PPE requirements) is included alongside standard regulatory documents.

MOQs vary by molecule. GLP-1 peptides typically start at 500 g (Tirzepatide) to 1 kg (Semaglutide). HPAPI molecules start at 100–200 g. High-volume generics (e.g. Metformin HCl) start at 50–100 kg. R&D samples may be available in smaller quantities — specify your needs in the inquiry form.

Yes — we ship API to over 60 countries. All shipments comply with applicable import/export regulations, including Health Canada, FDA, EMA, and relevant national authority requirements. Cold-chain shipping is available for temperature-sensitive APIs like GLP-1 peptides.

Lead times vary by molecule and order volume. GLP-1 peptides: 4–10 weeks. Oncology HPAPI: 4–8 weeks. High-volume generics: 2–6 weeks. All lead times are confirmed in writing as part of the Complete Source Quote.

GLP-1 peptide APIs require cold-chain logistics. We coordinate with qualified cold-chain carriers to ensure 2–8°C or −20°C shipping as required. Temperature excursion monitoring data and chain of custody documentation are provided with each shipment.

Yes. All inquiry information is treated as strictly confidential. We do not share your molecule requirements, quantities, or company details with third parties beyond what is necessary to prepare your quote. We are happy to execute a mutual NDA before detailed technical discussions.

Yes — for ongoing supply relationships, we execute Quality Agreements (QA) and, where applicable, Quality Technical Agreements (QTA) to define responsibilities, documentation standards, change control, and audit rights in accordance with ICH Q10.