However, a continuous independent quality evaluation for the marketed generic drugs is essential to enhance public confidence. In conclusion, the majority of the locally and regionally manufactured generic products being sold in the UAE market were of good quality and performed similarly to their comparators. Slight increase in heart rate (3 bpm) with concomitant therapy. Tadalafil for PAH: Avoid use in patients receiving long-term rifampin therapy. Loss on drying 731 Dry it at 105 for 2 hours: it loses not more than 2.0 of its weight. C: A solution (1 in 100) responds to the tests for Sulfate 191. Medium: dilute hydrochloric acid (1 in 100). Only one locally manufactured acetaminophen generic failed the USP dissolution tests before and after its storage and failed the disintegration test following its storage under accelerated conditions for zone IV. Tadalafil for ED and/or BPH: No dosage adjustments recommended. USP Reference standards 11 USP Hydroxychloroquine Sulfate RS.
Significant changes were observed following their storage over 6 months during accelerated stability studies, however, without failing the USP limits. Although results were statistically different from the comparators using ANOVA and Tukey’s Kremer post hoc tests, all tests were within the USP acceptance limits, except one, for friability, disintegration, content uniformity, and dissolution. All comparative tests were performed before storage and 3 and 6 months after storage during the accelerated stability study performed under the conditions for climatic zone IV (40 ☌ ± 2 ☌ /75% RH ± 5% RH). The Magnesium stearate is of vegetable origin. At least two generic products for each locally (L) and regionally (R) manufactured generic were evaluated according to the USP criteria in comparison to the brand (B) comparator product. Certificates of analyses are provided and show compliance with respective monographs.
Three drugs (tadalafil, rosuvastatin, and acetaminophen) from three different pharmacological classes were selected from the UAE market as representatives for generic drugs. This study aimed to evaluate the pharmaceutical equivalency of locally and regionally manufactured generic pharmaceutical products being sold in the United Arab Emirates (UAE) market to enhance public confidence, promote their utilization, and reduce treatment costs. They represent the majority of worldwide prescribed medicines therefore, their quality is critical to maximize patients’ therapeutic outcomes. In addition, USP is utilized in over 140 countries worldwide and integrated into the laws of more than 40 countries. Generic drugs or generic medicines are pharmaceutical products manufactured to be equivalent to the brand/innovator drug products.
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