The product boasts better quality than RLD: Inorganic salts are strictly controlled, chloride ions are less than 100ppm, and lithium are less than 25ppm.
With stable morph, gadobutrol API is more stable than the API from India.
The product is in line with the specifications of ChP, USP, EP, etc;
The production workshop of gadolinium contrast agent has passed USA FDA on-site audits, complying with USFDA cGMP.
There are dedicated and highly automated production lines for stable supply with well-ensured quality;
The injection excipient calcobutrol sodium and the API gadobutrol are available.
