Issued by: QbD Pharmaceutical (Cangzhou) Co., Ltd.
After joint research efforts across synthetic chemistry, analytical QC, process scale-up and stability evaluation teams, QbD Pharma has fully completed the entire R&D program for Orforglipron API (CAS No. 2212020-52-0), an oral small-molecule GLP-1 receptor agonist. We have fully established lab-scale synthesis, pilot amplification, industrial manufacturing routes, full impurity method validation and long-term stability testing systems. This milestone marks our official entry into the high-end oral GLP-1 metabolic API sector, enabling us to supply fully compliant, high-purity raw materials for formulation R&D manufacturers worldwide to support global regulatory filings.
As a globally blockbuster non-peptide oral GLP-1 candidate, Orforglipron differs from injectable peptide GLP-1 products. It allows once-daily oral administration without strict fasting or food restrictions, delivering superior glycemic control and weight loss effects compared with oral semaglutide proven in Phase 3 clinical trials. It serves as the core active pharmaceutical ingredient for innovative oral drugs treating Type 2 Diabetes Mellitus and obesity, with surging global demand for both pre-clinical R&D and commercial manufacturing. However, its complex synthetic pathway, high barrier to chiral impurity control, high mass-production costs and incomplete regulatory dossiers have long plagued the whole industry.
Led by our senior team of pharmaceutical synthetic scientists, this multi-round route iteration and process optimization project has overcome multiple technical bottlenecks, delivering three core competitive advantages:
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Self-Optimized Total Synthesis Route with Industry-Leading Production Cost
Our R&D team reconstructed chiral catalytic systems and streamlined multi-step complex reactions to drastically raise overall synthetic yield and cut consumption of precious metal catalysts and organic solvents. Verified via pilot and industrial batch trials, our comprehensive manufacturing cost delivers unmatched market competitiveness, with supply pricing superior to mainstream API manufacturers in China and India. Flexible supply solutions are available for lab trial samples, pilot batches and long-term annual framework orders.
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Rigorous Impurity Control with Consistent Purity ≥99.0%
We developed exclusive multi-stage low-temperature refining procedures to precisely regulate chiral impurities, related substances, heavy metals, residual solvents and all critical quality attributes. HPLC assay confirms consistent assay above 99.0%, with single individual impurity ≤0.2% and total impurities ≤1.0%. The finished product is uniform off-white crystalline powder with stable crystal form and excellent flowability, fully compliant with ICH and USP impurity guidelines. A full Certificate of Analysis (COA) is provided per batch, with all production executed in Class 100,000 GMP workshops to pass on-site audits from overseas pharmaceutical partners.
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Complete Type II DMF Dossier Ready for Global Regulatory Submission
We have finalized the full Type II Drug Master File (DMF) for Orforglipron, covering synthetic process development, impurity origin research, complete analytical method validation, 12-month long-term stability data, forced degradation studies, toxicology safety summaries and full GMP production records. The complete dossier can be directly submitted to clients across Europe, America, Central Asia, Azerbaijan, the Middle East, Southeast Asia and CIS countries for formulation clinical applications, drug import registration and marketing authorization, drastically shortening overseas registration timelines for our partners.
Manufacturing, Packaging & Cold Chain Logistics Support
Given Orforglipron’s light-sensitive property and low-temperature storage requirements, we adopt exclusive double-layer vacuum aluminum foil light-proof packaging: standard 25kg fiber drums with inner vacuum aluminum foil bag + light-blocking PE liner. Our factory owns independent constant-temperature low-temperature warehouses with stable long-term storage at -20℃±5℃, supported by global door-to-door cold-chain logistics to guarantee product stability without degradation during cross-border transit. Sample delivery, small pilot batch orders and long-term annual supply cooperation are now open for global pharmaceutical R&D institutes and formulation manufacturers.
QbD Pharma continuously invests in R&D for high-value specialty APIs including xanthine series and GLP-1 metabolic raw materials. The full completion of Orforglipron R&D further enriches our portfolio of innovative metabolic APIs. Moving forward, our R&D center will keep optimizing synthetic processes for the full GLP-1 molecule pipeline, consistently delivering cost-effective, fully compliant innovative APIs to fuel the development of oral therapeutics for metabolic diseases globally.
