Emcure Pharma gets USFDA Warning Letter for Manufacturing Violations at Pune plant Medical Dialogues Bureau16 Aug 2019 9:45 AM ISTIn the letter, the USFDA said inspectors during February 11-20 this year found significant deviations from standard manufacturing practices at Emcure...
Sun Pharma records Total Revenue of Rs 8374.36 crore for June quarter Medical Dialogues Bureau16 Aug 2019 9:30 AM ISTMumbai: India's largest drugmaker Sun Pharmaceutical Industries Ltd. (Sun Pharma) recently reported a consolidated net profit of Rs 1,387.48 crore...
Natco Pharma gets 6 USFDA observations for API facility near Hyderabad Medical Dialogues Bureau13 Aug 2019 1:16 PM ISTNatco Pharma said it will provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.NEW...
Indoco Remedies successfully completes USFDA inspection of CRO Anacipher in Hyderabad Medical Dialogues Bureau13 Aug 2019 9:45 AM IST"This is the fourth successive USFDA inspection with ZERO 483 for our CRO – AnaCipher," stated Ms Aditi Kare Panandikar, Managing Director, Indoco...
Cadila Healthcare gets OAI letter from USFDA for Moraiya facility Medical Dialogues Bureau8 Aug 2019 10:00 AM ISTThe company has received a letter from the USFDA classifying the inspection conducted at its Moraiya facility from April 22 to May 3 as OAI, Cadila...
Novartis concealed data problem before seeking approval for USD 2.1 million gene therapy Zolgensma: USFDA Medical Dialogues Bureau8 Aug 2019 9:15 AM ISTThe FDA said in a statement that AveXis Inc., the Novartis AG subsidiary that manufactures Zolgensma, told the agency five weeks after the approval of...
Natco Pharma gets EIR from USFDA for Kothur facility Medical Dialogues Bureau6 Aug 2019 4:35 PM ISTNew Delhi: Drug firm Natco Pharma on Monday said it has received establishment inspection report (EIR) from the US health regulator for its Kothur...
Lupin gets EIR from USFDA for Oral Dosage facility in Aurangabad Medical Dialogues Bureau5 Aug 2019 9:45 AM ISTLupin Ltd's Aurangabad facility is involved in the manufacture of Oral Solid Dosage, Oral Liquid and Powder for Oral Suspension products for the US...
Zydus Cadila wins USFDA nod for Minocycline Hydrochloride ER tablets to treat acne Medical Dialogues Bureau3 Aug 2019 9:45 AM ISTMinocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-modular moderate to severe acne vulgaris in...
Unichem Labs gets 4 USFDA observations for Goa formulation facility Farhat Nasim3 Aug 2019 9:39 AM ISTAt the end of an inspection, the facility received four observations, with no repeat observations and are mostly procedural in nature, Unichem Labs...
Cadila Healthcare Ankleshwar facility successfully completes USFDA inspection Medical Dialogues Bureau1 Aug 2019 9:25 AM IST"The United States Food and Drug Administration (USFDA) inspected the company's active pharmaceutical ingredient manufacturing facility located at...
Shilpa Medicare gets 5 USFDA observations for Raichur facility Medical Dialogues Bureau31 July 2019 9:30 AM IST"We have received Form 483 with five observations, with no repeat observations and any data integrity observations. The observations are mostly...
