Makwana, R. G., K. V. Desai, V. Kikani, and M. D. Vaja. “Regulatory Advances and Prospects of Variation Filing for the Registered Parenteral Products in USA and Europe”. International Journal of Drug Regulatory Affairs, Vol. 9, no. 2, June 2021, pp. 52-65, doi:10.22270/ijdra.v9i2.470.