Aarti Drugs receives EIR from USFDA for Tarapur API facility

This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP

Briefs: Gandhar Oil Refinery India, FDC and Apitoria Pharma

FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets

Supriya Lifescience inaugurates Rs. 125 crore new API production block in Maharashtra

The facility houses 33 reactors, comprising stainless steel and glass-lined varieties, with capacities ranging from 1.6 KL to 16 KL

Edwards’ SAPIEN 3 Ultra RESILIA Valve demonstrates positive outcome

Merck recommends rejection of TRC Capital’s “Mini-Tender” Offer

The offer price is approximately 4.32% below the closing price of the Merck common stock on November 11, 2024

Shilpa Pharma Lifesciences received CEP from EDQM for API, Octreotide

Octreotide is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis

Shilpa Pharma Lifesciences receives CEP from EDQM for API, Desmopressin

This is used to treat central diabetes insipidus and bedwetting

Apitoria Pharma gets Form 483 with 10 observations from USFDA

The observations are of procedural in nature and will be responded to within the stipulated time

DevCo completes strategic capital raise for investment in Medix Biochemica

The raised capital enables Medix Biochemica to continue execution of inorganic growth initiatives

USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations

The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices