IPP Bureau
Aurobindo Pharma receives USFDA approval for Cephalexin Tablets
By IPP Bureau - October 02, 2024
The product is expected to be launched in Q3FY25
SMS Pharma receives EDQM certification to supply Ibuprofen in Europe
By IPP Bureau - October 02, 2024
The inspection conducted by EDQM at its Visakhapatnam facility
Zydus receives tentative approval from USFDA for Enzalutamide Tablets
By IPP Bureau - October 02, 2024
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Dr. Reddy’s signs licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir
By IPP Bureau - October 02, 2024
Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022
Apitoria Pharma gets Form 483 with 10 observations from USFDA
By IPP Bureau - October 01, 2024
The observations are of procedural in nature and will be responded to within the stipulated time
Venus Remedies secures marketing authorisations for key oncology drugs from Morocco
By IPP Bureau - October 01, 2024
The authorization of bortezomib will enhance the company’s ability to deliver advanced cancer solutions in Southeast Asia
Morepen Laboratories appoints Amrit Ravi as Vice President
By IPP Bureau - October 01, 2024
He holds a Master’s in Management from the National University of Singapore
Krsnaa Diagnostics and Medikabazaar to invest Rs. 300+ crore to set up imaging centers
By IPP Bureau - October 01, 2024
The special financing terms offered by United Imaging and structured by Medikabazaar to Krsnaa Diagnostics underscore the strategic importance of this alliance
USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
By IPP Bureau - September 30, 2024
The inspection concluded with the issuance of a form 483 with five observations
USFDA inspection update on Jubilant HollisterStier’s Montreal facility
By IPP Bureau - September 30, 2024
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
Dr. Reddy's invests US$ 620 million in Switzerland subsidiary
By IPP Bureau - September 30, 2024
Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
By IPP Bureau - September 29, 2024
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA
By IPP Bureau - September 29, 2024
NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)
Amcor's long-term SBTi targets confirmed
By IPP Bureau - September 28, 2024
The net-zero target approval complements the company's near-term emission reduction targets
