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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)

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

India's Shilpa Medicare Sept-qtr profit rises
Monday, 13 Nov 2017 

Nov 13 (Reuters) - Shilpa Medicare Ltd ::Sept quarter profit 481.9 million rupees versus 331.9 million rupees year ago.Sept quarter revenue from operations 1.94 billion rupees versus 1.96 billion rupees year ago.  Full Article

India's Shilpa Medicare says Rajendra Dugar resigns as CFO
Tuesday, 24 Oct 2017 

Oct 24 (Reuters) - Shilpa Medicare Ltd :Says Rajendra Dugar resigns as CFO.  Full Article

Shilpa Medicare Dec-qtr profit falls
Tuesday, 14 Feb 2017 

Shilpa Medicare Ltd : Dec quarter net profit 273.5 million rupees versus profit 321.3 million rupees year ago .Dec quarter total income 1.76 billion rupees versus 1.90 billion rupees year ago.  Full Article

Shilpa Medicare gets USFDA approval for capecitabine tablets USP
Tuesday, 13 Dec 2016 

Shilpa Medicare Ltd :Shilpa Medicare -got approval from USFDA for capecitabine tablets USP, 150 mg and 500 mg to be bioequivalent and therapeutically equivalent to reference listed drug product.  Full Article

BRIEF-Shilpa Medicare Gets EU-GMP Certification From AGES For 2 API Manufacturing Plants, Formulation Facility

* GOT EU-GMP CERTIFICATION FROM AUSTRIAN AGENCY AGES FOR 2 API MANUFACTURING PLANTS IN KARNATAKA,FORMULATION FACILITY IN TELANGANA