The product boasts better quality than original RLD and drug products/API from China and other countries.
The product is tested with HPLC instead of the TLC in pharmacopoeia, with better specificity and sensitivity present, more stable and accurate results obtained, and more legible and reliable impurity profile available.
The product is in line with the specifications of ChP, USP, EP, JP, INP, KP, etc. Besides, the bacterial and endotoxin (≤0.025Eu/mg) of the product are way less than the specifications in pharmacopoeia of different countries. Therefore, customers shall have better quality control over the product.
The product boasts better quality than RLD: microorganism limits are strictly controlled, total aerobes are less than 10cfu/g, and bacterial endotoxin is less than 0.025EU/mg.
The API from India is more expensive and of interior quality to that produced by Poly.
The production workshop of cyclophosphamide in Anhui Poly has passed USA FDA on-site audits, complying with US FDA cGMP.
Production capacity and supply: There are dedicated and highly automated production lines for stable supply with well-ensured quality and an annual supply of over 10 tons.
The product has been filed/registered as an API in the markets of CN, US, EU, etc., the US MDF No. is 037154 (Status: A; has been referred to by drug products, under review) and the CN registration No. is Y20220000793 (Status: A). Besides, the product has been qualified by CN registration inspection, GMP compliance inspection, and US FDA on-site inspection.
