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Shilpa Medicare Ltd (SHME.NS)

SHME.NS on National Stock Exchange of India

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Latest Key Developments (Source: Significant Developments)

Shilpa Medicare's Raichur Site Gets U.S. FDA Form 483 With 5 Observations
Monday, 29 Jul 2019 

July 29 (Reuters) - India's Shilpa Medicare Ltd ::RECEIVED FORM 483 WITH 5 OBSERVATIONS AFTER U.S. FDA AUDIT AT RAICHUR SITE; OBSERVATIONS "MOSTLY PROCEDURAL".  Full Article

Shilpa Medicare Gets U.S. FDA Tentative Nod For ANDA, Bortezomid For Injection, 3.5Mg/Vial
Tuesday, 9 Apr 2019 

April 9 (Reuters) - Shilpa Medicare Ltd ::GETS U.S. FDA TENTATIVE APPROVAL FOR ITS ANDA, BORTEZOMID FOR INJECTION, 3.5MG/VIAL.  Full Article

Shilpa Medicare Gets USFDA Approval For Its ANDA, Gemcitabine For Injection USP
Monday, 25 Feb 2019 

Feb 25 (Reuters) - Shilpa Medicare Ltd ::SAYS GOT USFDA APPROVAL FOR ITS ANDA, GEMCITABINE FOR INJECTION USP, 200 MG/VIAL AND 1 G/VIAL.SHILPA MEDICARE-DRUG IS GENERIC EQUIVALENT OF DRUG USED IN TREATMENT OF OVARIAN CANCER, BREAST CANCER, NON-SMALL CELL LUNG CANCER & PANCREATIC CANCER.  Full Article

India's Shilpa Medicare Dec-Qtr Net PAT Falls
Thursday, 7 Feb 2019 

Feb 7 (Reuters) - Shilpa Medicare Ltd ::DEC QUARTER CONSOL NET PAT 124.7 MILLION RUPEES VERSUS 173 MILLION RUPEES YEAR AGO.DEC QUARTER CONSOL REVENUE FROM OPERATIONS 1.73 BILLION RUPEES VERSUS 1.86 BILLION RUPEES YEAR AGO.  Full Article

Shilpa Medicare Gets U.S FDA Nod For ANDA Imatinib Mesylate Tablets
Friday, 18 Jan 2019 

Jan 18 (Reuters) - Shilpa Medicare Ltd ::SAYS RECEIVED U.S FOOD AND DRUG ADMINISTRATION APPROVAL FOR ITS ANDA, IMATINIB MESYLATE TABLETS.SAYS DRUG USED IN TREATMENT OF LEUKEMIA AS RECOMMENDED IN LABEL APPROVED BY FDA .  Full Article

Shilpa Medicare Gets USFDA Approval For ANDA Irinotecan HCL Injection USP Single Dose Vials
Tuesday, 1 Jan 2019 

Jan 1 (Reuters) - Shilpa Medicare Ltd ::GETS USFDA APPROVAL FOR ANDA IRINOTECAN HCL INJECTION USP SINGLE DOSE VIALS.  Full Article

India's Shilpa Medicare's Dimethyl Fumarate Capsules Gets Tentative Approval By FDA
Friday, 16 Nov 2018 

Nov 16 (Reuters) - Shilpa Medicare Ltd ::CO'S ANDA FOR DIMETHYL FUMARATE DELAYED RELEASE CAPSULES 120 MG & 240 MG HAS BEEN GRANTED TENTATIVE APPROVAL BY FDA.  Full Article

India's Shilpa Medicare Gets EIR From U.S FDA For Karnataka API Units
Wednesday, 11 Jul 2018 

July 11 (Reuters) - Shilpa Medicare Ltd ::GETS EIR FROM U.S FDA TO API MANUFACTURING FACILITIES AT RAICHUR, KARNATAKA.SAYS INSPECTION WAS CARRIED OUT BETWEEN JANUARY 16 TO JAN 19.  Full Article

India's Shilpa Medicare Says U.S. FDA Issues 3 483 Observations To Co's Karnataka Units
Monday, 22 Jan 2018 

Jan 22 (Reuters) - Shilpa Medicare Ltd ::US FDA COMPLETED INSPECTION OF CO'S API FACILITIES UNIT-I AND UNIT-II LOCATED AT RAICHUR, KARNATAKA.SAYS INSPECTION CLOSED BY US FDA WITH THREE 483 OBSERVATIONS.IN PROCESS OF SUBMISSION OF CAPA PLAN TO REGULATOR WITHIN STIPULATED TIMELINES IN RESPONSE TO FORM 483 ISSUED.  Full Article

Shilpa Medicare Gets 483 Observations From U.S. FDA For SEZ Formulation Facilities In Telangana
Tuesday, 5 Dec 2017 

Dec 5 (Reuters) - Shilpa Medicare Ltd ::SAYS GOT 483 OBSERVATIONS FROM U.S. FDA IN RELATION TO SEZ FORMULATION FACILITIES SITUATED AT JADCHERLA, TELANGANA.SAYS TOTAL 10 OBSERVATIONS WERE CITED DURING CLOSE UP MEETING.SAYS 7 OBSERVATIONS ARE IMPROVEMENT IN PROCEDURES AND PRACTICES.SAYS 3 OBSERVATIONS RELATED TO SETTING OF ANALYTICAL SPECIFICATIONS, TEST PROCEDURES, METHOD VALIDATION.  Full Article