USFDA closes inspection at Shilpa Medicare Hyderabad lab Ruchika Sharma1 March 2024 4:52 PM ISTKarnataka: Shilpa Medicare has announced that the United States Food and Drug Administration (USFDA) has closed the inspection at the...
Shilpa Medicare secures Europe approval for smoking cessation drug Varenicline Ruchika Sharma26 Feb 2024 12:42 PM ISTVarenicline is indicated for smoking cessation in adults. It is used for quitting smoking.
Shilpa Medicare gets Germany marketing authorization for Amifampridine Tablets Ruchika Sharma20 Jan 2024 12:30 PM ISTHyderabad: Shilpa Medicare Limited has received Marketing Authorization from Germany, EU for Amifampridine Tablets, 10 mg under the National...
Submit PK-PD data of 3 cohorts for 7 days: CDSCO Panel Tells Shilpa Medicare on Ondansetron ER Inj Suspension IM study Dr. Divya Colin6 Jan 2024 5:30 PM ISTNew Delhi: Regarding the conduction of a study to evaluate the efficacy and safety of Ondansetron Extended-Release Injectable Suspension Intramuscular...
Shilpa Medicare Bengaluru unit gets TGA Australia nod for manufacturing medicinal Oral Mouth Dissolving Films Ruchika Sharma13 Dec 2023 1:30 PM ISTThis approval will enable the company to secure approval and market its Oral Film products in Australia.
Shilpa Medicare Jadcherla facility clears TGA, Australia GMP inspection Ruchika Sharma18 Oct 2023 2:30 PM ISTKarnataka: Shilpa Medicare has recently informed through a BSE filing that the Company’s finished dosage form manufacturing facility, Unit IV,...
Shilpa Pharma Lifesciences Unit II Raichur facility clears PMDA Japan GMP inspection Ruchika Sharma3 Sept 2023 1:15 PM ISTKarnataka: Shilpa Medicare Limited has announced that PMDA, Japan has successfully concluded GMP inspection without any critical/major observation at...
Shilpa Medicare receives UK-MHRA marketing nod for Betahistine Dihydrochloride Orodispersible Films Ruchika Sharma2 Sept 2023 1:30 PM ISTBetahistine is indicated for the treatment of vertigo, tinnitus, hearing loss and nausea associated with Meniere's syndrome and is available as...
Shilpa Biologicals gets marketing authorization permission for Adalimumab 40 mg/0.4mL injection in prefilled syringe in India Ruchika Sharma30 Jun 2023 12:30 PM ISTKarnataka: Shilpa Biologicals Private Limited (SBPL), a wholly owned subsidiary of Shilpa Medicare Limited (SML), has received the Marketing...
Shilpa Medicare gets USFDA VAI status for Hyderabad unit Ruchika Sharma22 May 2023 2:43 PM ISTKarnataka: Shilpa Medicare has announced that the US FDA GMP inspection performed on Company’s Analytical Services Division situated on first...
Shilpa Medicare Psoriatic arthritis drug Apremilast gets USFDA okay Ruchika Sharma11 April 2023 1:00 PM ISTKarnataka: Shilpa Medicare has recently announced that the Company has received final approval from the U.S Food and Drug...
Shilpa Medicare Analytical Services Division gets 2 minor observations from USFDA Ruchika Sharma11 March 2023 2:00 PM ISTKarnataka: Shilpa Medicare has announced that the US Food and Drug Administration (USFDA) has closed the inspection with two minor observations at the...
