Glenmark Pharma gets USFDA gesture for nervous system stimulant drug Kumar Jeetendra | January 29, 2021 Drug major Glenmark Pharma on Thursday said it has received final acceptance from the US health regulator for central nervous system stimulant medication Amphetamine Sulfate tablets. The approved product is a generic version of Evekeo tablets of Arbor Pharmaceuticals LLC. Quoting IQVIA sales statistics for the 12 month period ending November 2020, Glenmark said Evekeo …
Glenmark Pharma gets USFDA gesture for seizure treatment drug Kumar Jeetendra | February 4, 2021 Drug major Glenmark Pharma on Wednesday said it has received final approval from the US health regulator for Topiramate extended-release capsules, used to treat certain types of seizures. The approved product is a generic version of Qudexy XR Capsules of Upsher-Smith Laboratories, LLC. Glenmark Pharmaceuticals Ltd has received final approval from the United States Food …
Alembic Pharma gets five perceptions from USFDA for Gujarat office Kumar Jeetendra | February 8, 2021 Alembic Pharmaceuticals on Monday said the US health regulator has made five observations after inspection at its center at Karkhadi, Gujarat. “The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals” New Injectable Facility (F-3) located at Karkhadi from January 29-February 5, 2021. This was a scheduled inspection and at …
UK examining Serum Institute’s site in the midst of scramble for shots Kumar Jeetendra | February 15, 2021 Britain’s drug regulator is auditing manufacturing procedures in Serum Institute of India (SII) which could pave the way for AstraZeneca’s COVID-19 vaccine to be shipped from there to the UK and other countries, according to two sources close to the matter. SII, the world’s largest vaccine manufacturer, is now mass producing the AstraZeneca vaccine, developed …
USFDA rules against Sun Pharma Advanced Research Co’s’ allure with respect to cancer drug application Kumar Jeetendra | February 23, 2021 The Office of New Drugs (OND) of the US Food and Drug Administration (FDA) has denied the company”s appeal of the Comprehensive Response Letter (CRL) in relation to the New Drug Application (NDA) for Taclantis, Sun Pharma Advanced Research Company (SPARC) stated in a regulatory filing. In its letter, the OND asked the conduct of …
Dr Reddy’s gets 3 perceptions from USFDA for US-based API plant Kumar Jeetendra | March 10, 2021 Dr Reddy’s Laboratories on Wednesday said the US health regulator has issued a Form 483 with three observations after inspecting its Production facility in Middleburg, New York. The audit of the business’s active pharmaceutical ingredients (API) manufacturing plant at Middleburg, New York has been completed from the US Food and Drug Administration (USFDA), the Hyderabad-based …
Glenmark Pharmaceuticals gets USFDA gesture for conventional antipsychotic drug Kumar Jeetendra | March 24, 2021 Drug firm Glenmark Pharmaceuticals on Wednesday said it has received final approval from the US health regulator because of its generic phenothiazine antipsychotic Chlorpromazine Hydrochloride tablets. “The company has received approval from the United States Food and Drug Administration (USFDA) for Chlorpromazine Hydrochloride tablets USP, in the strengths of 10 mg, 25 mg, 50 mg, …
Caplin Point Laboratories arm gets USFDA gesture for Neostigmine Methylsulfate Injection Kumar Jeetendra | April 22, 2021 New Delhi: Caplin Point Laboratories on Thursday said its subsidiary has received approval from the US health regulator for Neostigmine Methylsulfate Injection. Neostigmine Methylsulfate Injection is a cholinesterase inhibitor and is indicated for the reversal of the effects of non-depolariSing neuromuscular blocking agents (NMBAs) after surgery. “Caplin Steriles Ltd (Caplin) has been granted final approval …
Glenmark Pharma gets USFDA gesture for Icatibant Injection Kumar Jeetendra | May 25, 2021 Drug major Glenmark Pharma on Monday said it has received final approval from the US health regulator for Icatibant Injection, indicated for the treatment of acute attacks of hereditary angioedema (HAE). Hereditary angioedema (HAE) is a disorder that results in recurrent attacks of severe swelling. The approved product is a generic version of Firazyr Injection …
Glenmark Pharma gets last gesture from USFDA for Theophylline ER tablets Kumar Jeetendra | June 4, 2021 Glenmark Pharma on Friday said it has received final approval from the US health regulator for Theophylline extended-release (ER) tablets. Theophylline extended-release tablets are used to prevent and treat wheezing, shortness of breath, and chest tightness caused by asthma, chronic bronchitis, emphysema, and other lung diseases. In a regulatory filing Glenmark Pharmaceuticals said it has …
Glenmark Pharma gets USFDA gesture for inhaltion drug Kumar Jeetendra | June 23, 2021 Drug maker Glenmark Pharma on Wednesday said it had received approval from the US health regulator for Arformoterol Tartrate Inhalation Solution, used to treat conditions like chronic bronchitis and emphysema, in the US market. The approved product is a generic version of Brovana Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc. “Glenmark Pharmaceuticals has …
Alembic Pharma gets last approval from USFDA for OCD treatment drug Kumar Jeetendra | August 5, 2021 New Delhi, Aug 5 (PTI) Drug firm Alembic Pharmaceuticals on Thursday said it has received final approval from the US health regulator for Clomipramine Hydrochloride capsules, used for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The company has received final approval from the US Food and Drug Administration (USFDA) for …
