China Manufacturing Landscape for Pimobendan (CAS 74150-27-9)
Pimobendan, the inodilator drug that has become the standard of care for canine congestive heart failure, is manufactured at our production facility in Jiangsu Province. As one of China’s leading veterinary cardiovascular API manufacturers, we supply Pimobendan directly to formulation companies developing chewable tablets, capsules, and oral solutions for the global companion animal market. Our direct manufacturer supply model eliminates intermediary costs while maintaining the quality standards demanded by veterinary regulatory authorities worldwide.
The veterinary pharmaceutical industry’s growing demand for Pimobendan — driven by increasing pet ownership, advancing veterinary cardiology, and expanded clinical indications — has made reliable API sourcing a strategic priority for formulators. Our established production capability and track record of consistent quality and delivery make us a trusted supply partner in this growing market segment.
Manufacturing Process & Facility
Our Pimobendan synthesis follows a validated multi-step chemical route featuring the construction of the benzimidazole-pyridazinone core structure. Key synthetic transformations include cyclization, hydrazine coupling, and final crystallization under controlled conditions to achieve the specified polymorphic form. The process has been optimized for high yield and minimal impurity formation across all stages.
Facility specifications:
- Dedicated production suites with glass-lined reactors from 300L to 5,000L
- ISO Class 7 cleanroom for final crystallization, drying, and packaging
- Automated process control with complete batch record documentation
- Polymorphic form control through validated crystallization conditions
- Annual production capacity: 10 metric tons of Pimobendan API
- On-site analytical laboratory with HPLC, XRPD, DSC, and dissolution testing
Our process development team maintains an ongoing optimization program focused on yield improvement, impurity profile enhancement, and particle size distribution control for optimal formulation performance.
Quality Standards & Multi-Pharmacopeial Compliance
Our Pimobendan API meets or exceeds USP and EP specifications:
| Parameter | Specification | Test Method |
|---|---|---|
| Appearance | White to yellowish-white crystalline powder | Visual |
| Identification | Positive by IR, HPLC, UV | IR/HPLC/UV |
| Assay (dried basis) | 98.5–101.5% | HPLC |
| Related Substances (total) | ≤0.5% | HPLC |
| Any Single Impurity | ≤0.10% | HPLC |
| Residual Solvents | Meets ICH Q3C | GC-HS |
| Elemental Impurities | Meets ICH Q3D | ICP-MS |
| Loss on Drying | ≤0.5% | 105°C, 2h |
| Polymorphic Form | Form A (confirmed) | XRPD |
| Particle Size (D50) | 10–30 μm (customizable) | Laser diffraction |
Regulatory Documentation
Our Pimobendan regulatory dossier supports veterinary drug product registrations globally:
- US FDA CVM Drug Master File — active and maintained
- EU ASMF available for veterinary mutual recognition and decentralized procedures
- China NMPA registration for veterinary API production
- Process validation covering three consecutive commercial-scale batches
- Stability studies per VICH GL3/GL5 guidelines with 36-month data
- Complete impurity qualification package with reference standards
- Polymorphic form characterization and stability data
- TSE/BSE free declaration
Our regulatory affairs team provides responsive support for customer registration projects, including customized documentation packages and rapid query responses.
Packaging & Logistics
Standard Pimobendan packaging configurations:
- Primary: Double polyethylene bags with desiccant, heat-sealed
- Secondary: Fiber drums (10 kg, 25 kg) or HDPE containers (500g, 1 kg, 5 kg)
- Light-protective outer packaging
- Storage: Below 25°C, protected from light and moisture
- Shelf life: 36 months from date of manufacture
Global shipping through established logistics partners. FOB, CIF, and DDP Incoterms available. Standard lead time is 10-15 business days for quantities up to 200 kg.
Competitive Pricing & Supply Reliability
Our Pimobendan pricing reflects the advantages of a dedicated, large-scale veterinary API manufacturer:
- Optimized synthesis with high overall yield and efficient resource utilization
- In-house intermediate production reducing dependency on external suppliers
- Large production capacity ensuring rapid fulfillment of commercial orders
- Strategic inventory maintenance for key customers with minimum 2-month safety stock
We serve the full spectrum of customer needs, from 50g formulation development samples to annual supply agreements of several metric tons. Volume-tiered pricing with long-term agreement incentives provides attractive commercial terms. Contact our veterinary cardiovascular API team for quotations and technical information.