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

USFDA delegation visits Divi's Laboratories’ Unit I at Choutuppal, Telangana

The delegation's visit covered a wide range of topics

USFDA inspection at Piramal Pharma’s Bethlehem facility

GeoVax secures multi-product license for ProBioGen's AGE1.CR.pIX suspension cell line

The AGE1.CR.pIX cell line's versatility allows it to support a wide range of viruses and vaccine types

Strides receives USFDA approval for Icosapent Ethyl Capsules

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)

Dishman Carbogen Amcis updates on inspection by EDQM and AIFA

The company's Bavla site was successfully jointly inspected by the EDQM and Italian Medicines Agency (AIFA)

Biocon Biologics receives European Commission approval for biosimilar of Aflibercept ‘Yesafili’

The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway

Zydus receives final approval from the USFDA for Clindamycin Phosphate Gel USP, 1%

Clindamycin Phosphate Gel is used to treat acne

USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA

InvaGen has received 5 inspectional observations in Form 483

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients

Ojjaara approved in the US as the first and only treatment for myelofibrosis patients with anaemia

Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy

Merck receives positive EU CHMP opinion for Keytruda as adjuvant treatment for cell lung cancer

Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial

Strides receives tentative USFDA approval for Dolutegravir/Lamivudine/Tenofovir Disproxil Fumurate tablets

Approval of this product under the PEPFAR program completes Strides’ qualification to all major markets and donor programs including Global Fund and South Africa

Zydus receives final approval from USFDA for Norelgestromin and Ethinyl Estradiol Transdermal System

Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of US $330 million in the United States

Strides receives tentative USFDA approval for Dolutegravir tablets

The products will be manufactured at the company's facility in Bengaluru

Bajaj Healthcare announces receipt of EIR from USFDA

The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations

Gufic Biosciences receives TGA Australia and ANVISA Brazil approval for Parecoxib 40mg injection

Parecoxib Sodium is the first parenteral selective COX-2 inhibitor available for clinical use in pain management

Strides receives USFDA approval for Sevelamer Carbonate for oral suspension

The products will be manufactured at the company's facility in Bengaluru

Caplin Steriles receives EIR from US FDA

The inspection classification was determined by the agency as Voluntary Action Indicated

Zydus receives final USFDA approval for Erythromycin Tablets

Erythromycin tablets is used to prevent and treat infections in many different parts of the body