Zydus receives final approval from USFDA for Lubiprostone Capsules, 8 mcg and 24 mcg

Lubiprostone capsule is indicated to treat certain types of constipation (chronic idiopathic constipation and irritable bowel syndrome with constipation)

Lupin receives tentative approval from USFDA for Obeticholic Acid Tablets

Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).

Zydus receives final and tentative approval from USFDA for Tofacitinib Tablets

Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)

Granules Consumer Health concludes FDA audit with zero observations

The audit is a pre-approval inspection for three products filed from the facility

Lupin receives approval from USFDA for Brexpiprazole Tablets

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)

Zydus granted Orphan Drug Designation by USFDA for ZYIL1

ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates

Glenmark receives ANDA approval for Prochlorperazine Maleate Tablets

According to IQVIA sales data for the 12-month period ending January 2023, the Compazine Tablets, 5 mg and 10 mg market achieved annual sales of approximately US $26.9 million

Caplin receives USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)

Bliss GVS Pharma gets 3 minor observations from USFDA for Palghar unit

The observations are procedural in nature

Briefs: Man Industries, Jeevan Scientific Technology, Unichem and Torrent Pharmaceuticals

Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores.

Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Hydrochloride Capsules USP

Cleocin Hydrochloride Capsules market achieved annual sales of approximately US $33.6 million

Shilpa Medicare gets 2 minor observations from USFDA for Unit VII, Analytical Services Division

The company will be submitting the responses to US FDA observations within stipulated timeline

USFDA completes inspection of Lupin’s Vizag facility

The inspection concluded with no observations

Zydus receives final approval from the USFDA for Erythromycin Tablets

Erythromycin Tablets USP, 250 mg and 500 mg are used to prevent and treat infections in many different parts of the body

Alembic receives USFDA tentative approval for Brexpiprazole Tablets

Alembic receives USFDA final approval for Prazosin Hydrochloride Capsules

Prazosin Hydrochloride Capsule is indicated for the treatment of hypertension, to lower blood pressure

Eugia Pharma receives USFDA approval for Lenalidomide Capsules

The approved product is indicated for the treatment of adult patients with Multiple myeloma, in combination with Dexamethasone

Caplin Steriles gets USFDA approval for Thiamine Hydrochloride Injection

Thiamine Hydrochloride Injection is effective in the treatment of vitamin B1 deficiency (beriberi)

Jubilant Pharmova receives VAI from USFDA for its API manufacturing facility

Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)

Alembic Pharmaceuticals gets USFDA final approval for fluorouracil injection

Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum and breast