The objective of this study was to determine the lymphocyte count of the test item Fingolimod Injectable lipid Suspension (7.0 mg/ml) after single dose intramuscular administration to Sprague Dawley rats. A total of 48 Sprague Dawley rats (24 males and 24 females) were randomly allocated to 4 groups. The total dose volume of placebo/test item was administered by intramuscular route and equal volume of the total dose volume was administered at two different sites (left and right thigh muscle). All the animals were observed once daily for clinical signs of toxicity and twice daily for mortality and morbidity throughout the experimental period. Body weights were recorded on treatment Day 1 (prior to dosing), days 7 and 14, and day 15 (fasting body weight). Site of injection was evaluated for erythema and oedema on the day of treatment at 1hr, 4hr, 6hr and 24hr post dosing. Ophthalmological examination was performed once during acclimatization for all the animals and during week 2 for Placebo control and high dose group animals (G1 and G4). Blood and urine samples were collected and analyzed on day 15 from all animals after overnight fasting. After blood collection, all the animals were euthanized under CO2 followed by exsanguination and subjected to gross pathological examination. The T/R ratio was calculated for the pharmacokinetic parameters of in cellular components, Cmax, Tmax, AUC0-t and MRT cumulatively calculated. The blood concentration versus time data shown the similar exposure for both test and reference formulations. The T/R ratio of blood for Cmax, Tmax, AUC0-t and MRT was found to be within the acceptable bioequivalence range which shows the equivalence of Test formulation with that of Reference formulation