[ad_1] Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). This approval makes Alembic’s product therapeutically equivalent to the reference listed drug Protonix I.V. for Injection, 40 mg/vial, manufactured by Wyeth Pharmaceuticals LLC. Pantoprazole sodium injection is used for […]
Zydus Life receives final approval from USFDA for Eluxadoline Tablets – CNBC TV18
[ad_1] Zydus Lifesciences has received final approval from the US Food and Drug Administration (USFDA) to manufacture Eluxadoline Tablets, 75 mg and 100 mg. Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea. Eluxadoline tablets will be produced at Zydus Lifesciences Ltd (SEZ) in Ahmedabad, the […]
Dr Reddy’s sells 14-drug portfolio to Senores Pharma for US market expansion – CNBC TV18
[ad_1] Dr Reddy’s Laboratories Ltd has entered into an agreement with Ahmedabad-based Senores Pharmaceuticals Ltd to sell a portfolio of 14 Abbreviated New Drug Applications (ANDAs) for an undisclosed amount, Senores Pharma said in a press release on Tuesday. The acquired portfolio consists of 13 ANDAs already approved by the US Food and Drug Administration […]
USFDA clears Zydus Lifesciences’ Ahmedabad facility with zero observation – CNBC TV18
[ad_1] Zydus Lifesciences Ltd on Friday announced that the United States Food and Drug Administration (USFDA) has completed an inspection at its facility in Ahmedabad with nil observations. Company Value Change %Change The US FDA concluded the inspection today with zero observations, the company announced in a press on Friday. The US health regulator inspected […]
Jubilant Pharmova shares in focus after USFDA issues five observations to its US-based subsidiary’s facility – CNBC TV18
[ad_1] Jubilant Pharmova shares will be in focus after the company on Thursday, January 16, reported that the USFDA issued five observations with no repeat observations to its subsidiary’s facility in the US. Company Value Change %Change The company said the United States Food and Drug Administration (USFDA) had inspected its subsidiary Jubilant Cadista Pharmaceuticals […]
Gland Pharma gains over 2% after USFDA clears Telangana manufacturing facility – CNBC TV18
[ad_1] Shares of Gland Pharma gained 2% in intraday trading on January 16, 2025, after the pharmaceutical company said it received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for an inspection conducted at the Dundigal facility in Hyderabad. Company Value Change %Change The company had earlier announced that […]
Aarti Drugs shares jump 11% after USFDA’s clearance for its Tarapur facility – CNBC TV18
[ad_1] Shares of Aarti Drugs shot up to 11% on Tuesday after the company announced that it received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its active pharmaceutical ingredient (API) manufacturing facility located in Tarapur, Maharashtra. Company Value Change %Change As at 15:26 IST on Tuesday, […]
USFDA says decongestant in many cold medicines doesn’t work. So what does? – CNBC TV18
[ad_1] Changes are coming to the cold and cough aisle of your local pharmacy: U.S. officials are moving to phase out the leading decongestant found in hundreds of over-the-counter medicines, concluding that it doesn’t actually relieve nasal congestion. Phenylephrine is used in popular versions of Sudafed, Dayquil and other medications, but experts have long questioned […]
Granules India subsidiary receives USFDA nod for ADHD treatment drug – CNBC TV18
[ad_1] Granules India Ltd has received approval from the United States Food and Drug Administration (USFDA) for Lisdexamfetamine Dimesylate chewable tablets, used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Company Value Change %Change The pharmaceutical company, in an exchange filing on Tuesday, said its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has been […]
Granules India says new product approval from Gagillapur could be impacted post USFDA action – CNBC TV18
[ad_1] Granules India Ltd. has informed the exchanges that the new product approvals from its crucial Gagillapur facility in Andhra Pradesh could be impacted after the US Food & Drug Administration (USFDA) classified the facility as an Official Action Indicated (OAI) on Tuesday, December 3. Company Value Change %Change “This classification does not impact the […]