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SMS Pharma receives EDQM certification to supply Ibuprofen in Europe
Drug Approval | October 02, 2024

SMS Pharma receives EDQM certification to supply Ibuprofen in Europe

The inspection conducted by EDQM at its Visakhapatnam facility


Krsnaa Diagnostics and Medikabazaar to invest Rs. 300+ crore to set up imaging centers
News | October 01, 2024

Krsnaa Diagnostics and Medikabazaar to invest Rs. 300+ crore to set up imaging centers

The special financing terms offered by United Imaging and structured by Medikabazaar to Krsnaa Diagnostics underscore the strategic importance of this alliance


USFDA inspection update on Jubilant HollisterStier’s Montreal facility
Drug Approval | September 30, 2024

USFDA inspection update on Jubilant HollisterStier’s Montreal facility

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures


Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
Drug Approval | September 29, 2024

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

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
Drug Approval | September 29, 2024

Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA

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)


Lupin signs distribution agreement with Celnova for orphan drug NaMuscla
Supply Chain | September 28, 2024

Lupin signs distribution agreement with Celnova for orphan drug NaMuscla

Agreement enables access of EU-approved treatment for myotonia symptoms in non-dystrophic myotonic disorders to patients from Argentina and Colombia


Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD
Drug Approval | September 27, 2024

Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD

Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype


Wockhardt's Zaynich cures complex case of meningitis caused by pan-drug resistant super-bug  under compassionate use
News | September 20, 2024

Wockhardt's Zaynich cures complex case of meningitis caused by pan-drug resistant super-bug under compassionate use

A multi-disciplinary team of senior physicians opted to use Zidebactam/Cefepime under compassionate use


Lupin receives USFDA approval for Bumetanide Injection
Drug Approval | September 19, 2024

Lupin receives USFDA approval for Bumetanide Injection

Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.


Lupin inks licensing agreement with Takeda to commercialize Vonoprazan
News | September 18, 2024

Lupin inks licensing agreement with Takeda to commercialize Vonoprazan

Takeda has granted Lupin non-exclusive patent licensing rights to commercialize Vonoprazan in India