Sai Life Sciences opens research facility SSRL

Fully equipped labs with 75-member team set-up and made operational in <100 days

NS Pharma announces FDA clearance to initiate phase II study for an Exon 44 skipping candidate

Study efficacy measures will include the expression of dystrophin protein and motor function.

SK Capital completes acquisition of Apotex

EIP Pharma and Diffusion Pharmaceuticals inks agreement to create CNS-focused company

EIP Pharma to initiate in 2Q 2023 a Phase 2b clinical study, funded in part by a $21 million grant from the National Institute of Aging

Alembic receives USFDA final approval for Brimonidine Tartrate Ophthalmic Solution

Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure

Lupin receives tentative approval from USFDA for Valbenazine capsules

Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).

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).

Granules Consumer Health concludes FDA audit with zero observations

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

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)