USFDA approves first treatment option for generalized pustular psoriasis flares in adults

Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares

USFDA inspection at Alembic Pharmaceuticals Injectable Facility (F-3) at Karkhadi

Zydus receives final approval from USFDA for two tablets

The group now has 322 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04

Stelis Biopharma’s flagship facility receives EIR from USFDA

The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise

Biological E. announces CDSCO recommendation of its infant’s vaccine

Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)

Granules India receives ANDA approval for Loperamide Hydrochloride and Simethicone Tablets

Lupin receives tentative approval from USFDA for Dasatinib Tablets

Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).

USFDA completes inspection at Aurolife Pharma’s Raleigh unit

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

Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP

he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).

Qdenga approved in Indonesia for use regardless of prior dengue exposure

Indonesia national agency for drug and food control, BPOM, approved QDENGA for use in individuals 6 to 45 years of age

Cipla receives 6 observations from USFDA for Goa facility

There are no data integrity (DI) observations.

Lupin receives UK MHRA Approval of Lutio for treatment of COPD

Lutio has the potential to offer significant cost savings when available to UK patients.

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).

Olaparib approved in Japan as adjuvant treatment for patients with high recurrent risk breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients

Lupin receives approval from US FDA for Formoterol Fumarate Inhalation Solution

Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US

Merck gets fast track designation from the USFDA for anticoagulant therapy

Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis

Glenmark receives OAI communication from US FDA

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

Unichem Laboratories receives ANDA approval for Carbamazepine Tablets

Carbamazepine Tablets are indicated for use as an anticonvulsant drug and in the treatment of the pain associated with true trigeminal neuralgia

Eugia Pharma receives USFDA pproval for Medroxyprogesterone Acetate injectable suspension

The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA

Wockhardt signs USFDA approved manufacturing partners

The company is relieving all its staff who were directly engaged by our US subsidiary in its plant in connection with the manufacturing process in a phased manner