Alembic Pharmaceuticals receives approval from USFDA for Temazepam Capsules

Alembic Pharmaceuticals has received an approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Temazepam Capsules USP 7.5mg, 15mg, 22.5mg and 40mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Restoril Capsules, 7.5mg, 15mg, 22.5mg and 40mg, of SpecGx LLC. Temazepam Capsules are … Read more

Zydus gets USFDA’s nod for Atorvastatin Calcium Tablets, Dimethyl Fumarate Delayed-Release Capsules

Zydus Cadila has received the final approval from the USFDA to market Atorvastatin Calcium Tablets in the strengths of 10 mg, 20 mg, 40 mg and 80 mg (US RLD —Lipitor). It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Atorvastatin is used along with a proper diet to help lower … Read more

Glenmark Pharma gets final approval from USFDA for Atovaquone Oral Suspension

Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Atovaquone Oral Suspension USP, 750 mg/5 mL, a generic version of Mepron Oral Suspension, 750 mg/5 mL, of GlaxoSmithKline LLC. According to IQVIA sales data, the Mepron Oral Suspension, 750 mg/5 mL market2 achieved annual sales … Read more

GMCH Successfully carries First Endoscopic Ampullectomy

Geetanjali Hospital’s Gastroenterologist’s Successful Attempt Udaipur : Gastroenterologist of Geetanjali Medical College & Hospital, Dr. Pankaj Gupta has successfully performed the first Endoscopic Ampullectomy of 52 years female suffering from a one centimeter tumor at the ampulla recently. The patient was referred from local hospital in view of abdominal pain. After evaluation and CT Scan … Read more

Zydus Cadila receives tentative approval from USFDA for Deferasirox Tablets

Zydus Cadila has received the tentative approval from the United States Food and Drug Administration (USFDA) to market Deferasirox Tablets, 90 mg, 180 mg, and 360 mg (US RLD – Exjade Tablets). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad in the state of Gujarat. It is used to treat … Read more

Zydus Cadila receives USFDA’s approval for Abacavir & Lamivudine Tablets, Fondaparinux Sodium Injection

Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Abacavir and Lamivudine Tablets USP, 600 mg/300 mg (US RLD- EPZICOM), and Fondaparinux Sodium Injection USP, 2.5 mg/0.5 mL, 5 mg/0.4 mL 7.5 mg/0.6 mL and 10 mg/0.8 mL single-dose (US RLD- ARIXTRA). Abacavir and Lamivudine Tablets … Read more

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