Natco Pharma receives 8 observations from USFDA for Pharma Division at Kothur

The company is confident of addressing all the observations within the stipulated time

Zhimeng Biopharma CB03 receives Orphan Drug Designation from the USFDA

CB03 is a candidate drug for the treatment of ALS and other central nerve system (CNS) diseases

FDA approves only vaccine Penbraya for treatment of meningococcal disease in adolescents

The vaccine further advances Pfizer’s vaccine portfolio and builds on more than 20 years of expertise and knowledge in the prevention of meningococcal disease

Granules India receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules

Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)

USFDA approves Pfizer’s Velsipity for adults with Ulcerative Colitis

Approval of oral, once-daily VELSIPITY based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials

USFDA inspection at Biocon Biologics' manufacturing facility in Johor, Malaysia

Shilpa Medicare Unit IV, Jadcherla has cleared TGA, Australia GMP inspection

This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years

Glenmark receives ANDA approval for Apremilast Tablets

Glenmark's current portfolio consists of 188 products authorized for distribution in the US

Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations

The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally

Lupin gets tentative approval from USFDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution

Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch

Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib

The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials

Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart

The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022

Zydus receives final approval from the USFDA for Sugammadex Single-Dose Vial

Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide

Lupin receives tentative approval from USFDA for Tolvaptan Tablets

Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)

Asahi Kasei Pharma files application for approval to manufacture and sell Cresemba Capsule

The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg

Marksans Pharma gets USFDA approval for Esomeprazole Magnesium delayed-release capsules

This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals

Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets

The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products

Alembic received 6 USFDA approvals during Q2FY24

The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets

Strides receives USFDA approval for Icosapent Ethyl capsules

The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin

Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility

The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated