The in-house control limit of unspecified impurities is NMT 0.05%;
The in-house control limit of bromine ions is NMT 250ppm;
The product is in line with the specifications of ChP, EP, and USP.
The product has received EU CEP certificate, WC certificate and GMP certificate and is under the review of US DMF and CN for registration. Applications for marketing authority in other markets can be submitted according to customer requirements.
There are dedicated production lines for stable supply.
The annual production capacity is over 20tons;
Related product information
PDF file
Dobutamine Hydrochloride USP DMF 035217 - AC letter.pdf
