Bliss GVS Pharma updates on inspection by USFDA

The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection

Zydus receives final approval from the USFDA for Diclofenac Sodium and Misoprostol Delayed Release Tablets

Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States

Zydus receives final approval from USFDA for Esomeprazole Magnesium

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)

Zydus receives final approval from the USFDA for Tadalafil Tablets USP

Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)

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

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

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

Zydus receives final approval from the USFDA for Metronidazole Topical Cream

Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea

Zydus receives final approval from the USFDA for Icosapent Ethyl Capsules

Icosapent Ethyl Capsules are indicated as an adjunct to diet to reduce triglyceride levels