China Manufacturing Landscape for Omeprazole (CAS 73590-58-6)
Omeprazole, the proton pump inhibitor that transformed gastroenterology, is one of the highest-volume pharmaceutical APIs manufactured in China. Our production facility in Shandong Province operates one of China’s largest dedicated Omeprazole production lines, supplying pharmaceutical formulators in over 60 countries. As a direct manufacturer source with annual capacity exceeding 200 metric tons, we provide the scale, quality, and pricing that global generics companies require for this essential medicine.
China produces the majority of the world’s Omeprazole API, and our facility stands among the top tier of manufacturers by volume, quality certifications, and regulatory approvals. Our 20-year track record in Omeprazole production, combined with continuous investment in facility modernization and quality system enhancements, positions us as a preferred long-term supply partner.
Manufacturing Process & Facility
Our Omeprazole synthesis employs a well-established chemical process involving the oxidation of the corresponding sulfide intermediate to the sulfoxide. The process is highly controlled to prevent over-oxidation to the sulfone impurity, using proprietary oxidation conditions that achieve consistently high selectivity. Final purification involves pH-controlled crystallization to yield the desired polymorphic form.
Facility capabilities:
- Large-scale production facility with reactor capacity from 1,000L to 10,000L
- Automated oxidation reactors with precise temperature and reagent dosing control
- Dedicated crystallization suites with programmable cooling profiles
- ISO Class 7 cleanroom for final drying, milling, and packaging
- Annual production capacity: 200+ metric tons of Omeprazole API
- Pelletization and enteric coating capabilities for semi-finished dosage forms
Our production operates on a continuous campaign basis, with multiple campaigns per year ensuring consistent availability and fresh inventory for customers worldwide.
Quality Standards & Multi-Pharmacopeial Compliance
Our Omeprazole API simultaneously meets USP, EP, BP, JP, and ChP monograph requirements:
| Parameter | Specification | Test Method |
|---|---|---|
| Appearance | White to off-white powder | Visual |
| Identification | Positive by IR, HPLC, UV | IR/HPLC/UV |
| Assay (dried basis) | 98.5–101.0% | HPLC |
| Related Substances (total) | ≤0.5% | HPLC |
| Omeprazole Sulfone | ≤0.10% | HPLC |
| Any Other Single Impurity | ≤0.10% | HPLC |
| Residual Solvents | Meets ICH Q3C | GC-HS |
| Elemental Impurities | Meets ICH Q3D | ICP-MS |
| Loss on Drying | ≤0.5% | 60°C, vacuum |
| Particle Size | D90 ≤200 μm (standard); micronized available | Laser diffraction |
Regulatory Documentation
Our Omeprazole regulatory portfolio is one of the most complete among Chinese API manufacturers:
- US FDA Drug Master File (Type II) — active with successful FDA inspection history
- EU CEP (Certificate of Suitability) — granted and maintained current
- Japan PMDA DMF — filed and active
- WHO Prequalification — granted
- Korea MFDS, Brazil ANVISA, and multiple other national registrations
- China NMPA registration
- Complete ICH Q1A stability program with 60-month real-time data
- Nitrosamine risk assessment and confirmatory testing per FDA/EMA requirements
Our dedicated regulatory affairs department manages over 50 active registrations globally, with an experienced team providing rapid documentation support for customer filings.
Packaging & Logistics
Omeprazole packaging addresses the compound’s sensitivity to moisture and light:
- Primary: Aluminum foil-lined polyethylene bags, nitrogen-flushed, heat-sealed
- Secondary: Fiber drums (25 kg net) or aluminum-lined cartons (5 kg, 10 kg)
- Desiccant sachets included in each packaging unit
- Storage: Below 25°C, protected from light and moisture
- Shelf life: 36 months from date of manufacture
We ship from Qingdao and Shanghai ports with weekly container availability to all major global destinations. FOB, CIF, CFR, and DDP terms are standard. Bulk shipment discounts are available for full container load orders.
Competitive Pricing & Supply Reliability
As one of the highest-volume Omeprazole producers in China, our pricing reflects maximum economies of scale:
- Largest-scale production driving the lowest per-unit manufacturing costs
- Complete backward integration of key intermediates
- Highly optimized synthetic process with industry-leading yields
- Efficient solvent recovery reducing both costs and environmental impact
We accommodate orders from 5 kg to multi-ton quantities per shipment, with annual supply agreements supporting the largest global generics manufacturers. Volume-tiered pricing with annual escalation caps provides commercial predictability. Contact our GI API sales team for current pricing, sample requests, and technical documentation.