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Results For "US-FDA"

337 News Found

Aarti Drugs Q4FY 22 consolidated revenue grew by 39 per cent YoY
News | May 10, 2022

Aarti Drugs Q4FY 22 consolidated revenue grew by 39 per cent YoY

The capex for FY22 stood at Rs 145 crore and is expected to be in the range of Rs 250-350 crore for the entire FY23 which would be funded through a mix of internal accruals and debt


Sun gets 10 observations from USFDA for Halol facility
News | May 10, 2022

Sun gets 10 observations from USFDA for Halol facility

The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days


Gland launches Bortezomib in the US market
Drug Approval | May 04, 2022

Gland launches Bortezomib in the US market

Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma


We continue to invest in R&D and new product development: Anish Bafna, CEO & MD, Healthium Medtech
interviews | April 22, 2022

We continue to invest in R&D and new product development: Anish Bafna, CEO & MD, Healthium Medtech

Healthium Medtech, a company focused on products used in surgical, post-surgical and chronic care has ramped up its play in the global healthcare industry. In an interview with Thomas C. Thottathil, Editor, Indian Pharma Post, Anish Bafna, CEO and MD, Healthium Medtech outlines his plans


Good business performance gives Boehringer Ingelheim tailwind for investment in R&D
Biotech | April 05, 2022

Good business performance gives Boehringer Ingelheim tailwind for investment in R&D

R&D investment up 11.7% to 4.1 billion EUR in 2021 (20.0% of net sales)


Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
Biotech | April 01, 2022

Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion

Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product


BioVaxys expands cancer vaccine platform
Biotech | March 31, 2022

BioVaxys expands cancer vaccine platform

BVX-0922 to target colorectal cancer under investigator-sponsored IND


Jeffrey W. Fisher is the recipient of the Arnold J Lehman SOT award
News | March 16, 2022

Jeffrey W. Fisher is the recipient of the Arnold J Lehman SOT award

Career achievement for contributions in Physiologically based pharmacokinetic (PBPK) and biologically based does response (BBDR) modelling tools


Granules Pharmaceuticals clears USFDA audit
News | March 15, 2022

Granules Pharmaceuticals clears USFDA audit

This is the sixth successful USFDA audit for this facility


USFDA clears Niramai's breast thermography device
News | March 14, 2022

USFDA clears Niramai's breast thermography device

The SMILE-100 System is a breast thermography device that helps healthcare personnel review, measure and analyze thermally significant indications in the breast region