Zenara Pharma launches the first generic of Paxlovid for COVID-19 in India

Pfizer’s Paxlovid is approved by US FDA for COVID treatment

Granules India receives ANDA approval for Loperamide Hydrochloride and Simethicone Tablets

USFDA completes inspection at Aurolife Pharma’s Raleigh unit

The unit has filed 2 Derma products and 1 MDI product.

Glenmark receives OAI from USFDA for Goa facility

Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.

Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER

Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).

Sun Pharma gets OAI from USFDA for Halol facility

The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved

Jubilant Pharmova gets 6 observations from USFDA for its facility at Roorkee

he US FDA has issued six observations pursuant to the completion of the audit.

USFDA issues 3 observations for Aurobindo Pharma’s Unit XI

The company has responded to the warning letter and carried out the committed corrections.

Ascentage Pharma and Tanner Pharma Group initiate a global innovative named Patient Program

Tanner will be the supplier of olverembatinib to healthcare providers on a named patient basis in countries where the drug is not commercially available.

Dr. Reddy's Laboratories updates on PAI of formulations facility

The company has been issued a Form 483 with two observations which the company will address within the stipulated timeline.