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Results For "US-FDA"

251 News Found

Hikal posts FY23 PAT at Rs. 36 Cr
News | May 30, 2023

Hikal posts FY23 PAT at Rs. 36 Cr

Pharmaceutical sales was flat and stood at Rs. 309 crore as compared to Rs. 308 crore in Q4 FY22


Shilpa Medicare Analytical Services Division gets VAI status from USFDA after GMP inspection
Drug Approval | May 23, 2023

Shilpa Medicare Analytical Services Division gets VAI status from USFDA after GMP inspection

This is the second US FDA GMP inspection of this facility within one year


Granules India received ANDA approval for Venlafaxine ER capsules
Drug Approval | May 20, 2023

Granules India received ANDA approval for Venlafaxine ER capsules

Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder


Hikal announces USFDA audit with zero observations
Drug Approval | May 16, 2023

Hikal announces USFDA audit with zero observations

This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites


Medico Remedies to foray into ointment manufacturing segment
News | May 15, 2023

Medico Remedies to foray into ointment manufacturing segment

The facility will have a capacity to manufacture upto 3 million tubes monthly


Formosa Pharmaceuticals and AimMax Therapeutics announce NDA Submission to USFDA for APP13007
Drug Approval | May 08, 2023

Formosa Pharmaceuticals and AimMax Therapeutics announce NDA Submission to USFDA for APP13007

APP13007 is a novel aqueous nanosuspension formulation for the treatment of inflammation and pain following ocular surgery


Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA
Medical Device | May 05, 2023

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA

Pheezee is designed to assess musculoskeletal and neuromuscular health.


USFDA puts on hold Sun Pharma trials on dermatological drug
Drug Approval | May 04, 2023

USFDA puts on hold Sun Pharma trials on dermatological drug

Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose


Ipca Laboratories gets 3 observations for Piparia, Silvassa unit
Drug Approval | April 27, 2023

Ipca Laboratories gets 3 observations for Piparia, Silvassa unit

The company will submit its comprehensive response on these observations to the US FDA within the stipulated time


USFDA suggests corrective measures to Sun Pharmaceutical’s Mohali facility
Drug Approval | April 24, 2023

USFDA suggests corrective measures to Sun Pharmaceutical’s Mohali facility

The USFDA had classified the inspection as "Official Action Indicated" (OAI).