Aurobindo Pharma Q2 net profit up by 5 pc to Rs 640 crore Medical Dialogues Bureau14 Nov 2019 9:30 AM ISTManaging director of Aurobindo Pharma N Govindarajan said We had another quarter of healthy performance where we continued to grow in the US and...
Laurus Labs gets 2 USFDA observations for Visakhapatnam facility Farhat Nasim10 Nov 2019 10:00 AM ISTNew Delhi: Drug firm, Laurus Labs Ltd. recently said in a filing that the US health regulator has issued two observations after the inspection of its...
Shilpa Medicare gets USFDA approval for generic equivalent of cancer drug TARCEVA Farhat Nasim8 Nov 2019 10:00 AM ISTErlotinib Tablets, 25 mg, 100 mg, and 150 mg is a generic equivalent of reference listed drug (RLD) TARCEVA used in the treatment of patients with...
Strides Pharma Ranitidine tablets within acceptable NDMA limits, says USFDA Medical Dialogues Bureau4 Nov 2019 4:31 PM ISTNew Delhi: Drug firm, Strides Pharma recently announced that the USFDA issued a statement1 on November 1, 2019, providing an update with the latest...
Dr Reddys Srikakulam plant gets 4 USFDA observations Farhat Nasim29 Oct 2019 10:00 AM ISTThe audit of Dr Reddy's API Srikakulam Plant (SEZ) by the United States Food and Drug Administration (USFDA) was completed on Friday, the...
Alkem Labs Bioeguivalcnce Center at Taloja clears USFDA inspection Medical Dialogues Bureau28 Oct 2019 10:00 AM IST"This is to inform that the US FDA had conducted an inspection at Alkem Laboratories Ltd's Bioequivalence Center located at Taloja, Maharashtra from...
Shilpa Medicare Telangana facility gets EIR from USFDA Medical Dialogues Bureau26 Oct 2019 11:46 AM IST"The USFDA has concluded that the inspection classification of Jadcherla facility was "voluntary action indicated". This facility is in an acceptable...
Mylan moves application with DCGI to launch new TB drug Pretomanid in India Medical Dialogues Bureau16 Oct 2019 4:10 PM IST"We have submitted the new drug application to the office of DCGI. We are in an advanced stage of discussion and are working with the office of...
Morepen Labs adds blockbuster Rivaroxaban, Vildagliptin, UDCA to API portfolio Farhat Nasim14 Oct 2019 1:36 PM ISTWhile two products Rivaroxaban and Vildagliptin will augment Morepen Lab's presence in the cardiac and diabetic segments respectively, the third...
FIRST: Sun Pharma unveils dry-eye treatment drug CEQUA in US Farhat Nasim14 Oct 2019 1:13 PM ISTNew Delhi: Through a release, drug major, Sun Pharmaceutical Industries Ltd. (Sun Pharma) today announced that one of its wholly-owned subsidiaries...
Cadila Healthcare largest API manufacturing site clears USFDA inspection Medical Dialogues Bureau12 Oct 2019 11:41 AM ISTThe US Food and Drug Administration (USFDA) inspected the company's active pharmaceutical ingredients (API) manufacturing facility at Dabhasa from...
Aurobindo Pharma Unit-7 documents inaccurate, misleading: USFDA Medical Dialogues Bureau11 Oct 2019 10:00 AM IST"The responsibilities and procedures applicable to the quality control unit are not fully followed. Several lists of documents requested were either...
