AstraZeneca receives CDSCO approval for Tremelimumab combination in India

Tremelimumab in combination with Durvalumab is indicated for the treatment of patients with unresectable hepatocellular carcinoma (uHCC)

USFDA inspects contract manufacturing facility of Jubilant Pharmova at Montreal Canada

The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.

Lupin receives USFDA approval from Obeticholic Acid Tablets

Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).

Concept Medical gets 4th IDE approval from USFDA

For the treatment of Superficial Femoral Artery

Eugia Pharma receives USFDA approval for Carboprost Tromethamine Injection

The product is expected to be launched in June 2023

Venus Remedies gets Kenyan GMP certification for its manufacturing facilities in Baddi

The approval paves the way for consolidating the company’s position in Kenya and other African markets as part of its global expansion plans

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

Zydus receives final approval from the USFDA for Ephedrine Sulfate Injection

Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States

Strides Puducherry facility receives EIR from USFDA

The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.

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

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

USFDA approves Astellas' Veozah’ for treatment of vasomotor symptoms due to menopause

VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause

USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’

Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time

Venus Remedies bolsters its position in oncology space with marketing approval from Philippines, Iraq

The company moves a step closer towards achieving its goal of emerging as the top oncology medicine supplier from India in the ASEAN region

IOL Chemicals and Pharmaceuticals receives CEP for Paracetamol to export in European market

The certification issued by the EDQM verifies the compliance of pharmaceutical substances

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

Zydus receives final approval from the USFDA for Sucralfate Tablets USP, 1 gram

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.

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

Laurus Labs receives USFDA tentative approval for Dolutegravir 5mg and 10mg in HIV/AIDS treatment

It will help in bringing a significant benefit in compliance of ARV medication in the paediatric HIV treatment