Sun Pharma Advanced Research Company Ltd. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for PDP-716 for the treatment of patients with Glaucoma, due to inspection findings at a third-party Active Pharmaceutical Ingredient (API) manufacturing facility. The FDA did not raise any issues with the PDP-176 clinical efficacy or safety and no additional clinical data or trials have been requested. SPARC is committed to work closely with Visiox, the FDA and the third-party manufacturer to resubmit the NDA as quickly as possible.
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5-day change | 1st Jan Change | ||
213.3 INR | -1.16% | -1.59% | -25.40% |
1st Jan change | Capi. | |
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-25.40% | 854M | |
+37.78% | 705B | |
+32.82% | 583B | |
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+5.14% | 291B | |
+16.64% | 238B | |
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+10.63% | 209B | |
+9.32% | 169B |
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- Sun Pharma Advanced Research Company Limited Announces That FDA Issues Complete Response Letter for Pdp-716 Nda Due to Inspection Findings At Third-Party Api Manufacturing Facility