GLENMARK PHARMACEUTICALS LTD. - 532296 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
Glenmark Pharmaceuticals receives ANDA approval for Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg Glenmark stock slips to 6-year low after USFDA issues CRL on Ryaltris
The company further said it would continue to pursue regulatory approval for Ryaltris Glenmark Pharmaceuticals Ltd - 532296 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
Glenmark to partner with Novartis to promote, commercialize and distribute three respiratory products in Brazil Glenmark Pharma says USFDA has issued CRL for Ryaltris
Glenmark Pharmaceuticals on Saturday said the US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the new drug appl Glenmark Pharmaceuticals Ltd - 532296 - FDA Issues Complete Response Letter For Ryaltris(tm) (Olopatadine Hydrochloride [665 Mcg] And Mometasone Furoate [25 Mcg])
We would like to inform you that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application for Ryaltris(tm) (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray. The CRL cites deficiencies in the Drug Master File (DMF) pertaining to one of the active pharmaceutical ingredients (APIs) and in the manufacturing facilities. The CRL does not specify any deficiencies with the clinical data supporting the New Drug Application for Ryaltris. We feel confident that we should be able to resolve these issues within the next 6 to 9 months. Glenmark Pharmaceuticals will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps. This is for your information and record please. Glenmark Pharma gets USFDA nod for VAGIFEM
US health regulator approves Glenmark Pharma for generic version of Nordisk Inc's VAGIFEM. Glenmark Pharmaceuticals Ltd - 532296 - Announcement under Regulation 30 (LODR)-Press Release / Media Release
Glenmark Pharmaceuticals receives tentative ANDA approval for Clindamycin Phosphate Foam, 1% Glenmark Pharmaceuticals Ltd - 532296 - Reg.24(A)-Annual Secretarial Compliance
Annual Secretarial Compliance Report Sr. No. Particulars Details 1Period for which the report has been issued 31/03/2019 2Date of Report29/05/2019 3 Name of the Certifying Firm S.S. Rauthan & Associates 4 Name of the Certifying Individual Surjan Singh Rauthan 5Membership TypeFCS 6 Membership Number 4807 7 CP No. 3233 8 Whether any observations/qualification reported by the Secretarial Auditor ? NO Glenmark Pharmaceuticals Ltd - 532296 - Board recommends Dividend
Glenmark Pharmaceuticals Ltd has informed BSE that the Board of Directors of the Company at its Meeting held on May 29, 2019, inter alia, has recommended Dividend @ 200% i.e. Rs. 2/- per share (face value of Re. 1/- each) on the Equity Share Capital of the Company for the financial year 2018-19 subject to the approval of the Shareholders at the ensuing Annual General Meeting.