USFDA completes audit for Dr Reddys Shreveport plant, no observations issued Medical Dialogues Bureau23 Feb 2019 9:30 AM IST"The audit of our formulations Shreveport plant, Louisiana, USA, by the United States Food and Drug Administration (USFDA) has been completed with...
Dr Reddys recalls 2770 bags of Levetiracetam Sodium Chloride injection in US market Farhat Nasim22 Feb 2019 11:53 AM ISTAs per the latest Enforcement Report of the US Food and Drug Administration (USFDA), Dr Reddys is recalling Levetiracetam in 0.54 per cent Sodium...
Alembic Pharma gets USFDA nod for Acetazolamide extended release capsules Farhat Nasim21 Feb 2019 9:45 AM ISTAcetazolamide extended-release capsule is therapeutically equivalent to the reference listed drug, Diamox Sequels, 500 mg, of Teva Branded...
Alembic Pharma gets USFDA nod for Olopatadine Hydrochloride ophthalmic solution Farhat Nasim17 Feb 2019 9:30 AM ISTThe company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Olopatadine...
GSK Consumer profit rises 35 percent to Rs 221.06 crore in December quarter Garima16 Feb 2019 9:20 AM IST"The merger is now subject to the receipt of other necessary statutory and regulatory approvals under applicable laws. The merger process is moving...
Dr Reddys launches Tadalafil tablets for treating erectile dysfunction Farhat Nasim13 Feb 2019 12:31 PM ISTNew Delhi: Hyderabad based drug major, Dr Reddy's has recently launched Tadalafil tablets in the US market. The drug launched is used to treat...
Glenmark gets tentative USFDA nod to breast cancer injection Fulvestrant Farhat Nasim8 Feb 2019 11:40 AM ISTFulvestrant injection is a generic version of AstraZeneca Pharmaceuticals LP's Faslodex injection in the same strength, it added. The Faslodex...
Strides to exit investment in Arrow Pharma for over Rs 2000 crore Medical Dialogues Bureau30 Jan 2019 9:30 AM IST"Strides will receive AUD 300 million as upfront payment at the closure of the transaction, while the balance AUD 94 million to be deferred through a...
Glenmark gets tentative USFDA nod for Abiraterone Acetate tablets Medical Dialogues Bureau24 Jan 2019 9:30 AM ISTGlenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration for Abiraterone Acetate tablets...
Aster DM Healthcare to focus on Expansion in South, West India, to invest Rs 650 crore: Report Farhat Nasim21 Jan 2019 2:13 PM IST"Our idea is to focus only on tertiary care in cities and we are exploring new facilities in Mumbai, Pune and in Thiruvananthapuram, where we have...
Dr Reddy's gets four observations from USFDA for Andhra plant Medical Dialogues Bureau19 Jan 2019 9:30 AM IST"The audit of our formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh by the US Food and Drug Administration (USFDA), has been completed today....
Lupin gets USFDA nod for generic schizophrenia drug Medical Dialogues Bureau8 Jan 2019 12:10 PM ISTNew Delhi: Drug maker Lupin Monday said it has received approval from the US health regulator to market Lurasidone Hydrochloride tablets, used in the...