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Results For "U.S.-FDA"

246 News Found

Biocon Sdn. Bhd. enters Malaysia Book of Records
Biotech | August 08, 2022

Biocon Sdn. Bhd. enters Malaysia Book of Records

The 562,000 square feet facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by MBR


Lupin Q1 FY23 consolidated loss drops to Rs. 89.08 Cr
News | August 04, 2022

Lupin Q1 FY23 consolidated loss drops to Rs. 89.08 Cr

Lupin is the 6th largest company in the Indian Pharmaceutical Market


USFDA conducts inspection at Glenmark's Aurangabad manufacturing facility
News | July 04, 2022

USFDA conducts inspection at Glenmark's Aurangabad manufacturing facility

The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.


Glenmark Pharmaceuticals expand its OTC portfolio
News | June 29, 2022

Glenmark Pharmaceuticals expand its OTC portfolio

The over-the-counter market has long been an important segment of Glenmark’s portfolio around the world


Glenmark Pharmaceuticals to address USFDA’s observation
News | June 23, 2022

Glenmark Pharmaceuticals to address USFDA’s observation

U.S. FDA has issued Form 483 with six observations after an inspection of the company’s formulation manufacturing facility based out of Baddi


Glenmark Pharma gets observations from USFDA for its Goa and Monroe facilities
News | May 22, 2022

Glenmark Pharma gets observations from USFDA for its Goa and Monroe facilities

A total of five observations for Goa and 17 for Monroe


Glenmark receives sANDA approval for Abiraterone Acetate tablets
Drug Approval | May 20, 2022

Glenmark receives sANDA approval for Abiraterone Acetate tablets

According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million


Grand Opening of Kodiak Sciences’ bioconjugation facility
Biotech | May 19, 2022

Grand Opening of Kodiak Sciences’ bioconjugation facility

Purpose-built bioconjugation facility in Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases


Ascletis announces U.S. IND approval of ASC22 for HIV patients
Biotech | May 11, 2022

Ascletis announces U.S. IND approval of ASC22 for HIV patients

ASC22 (Envafolimab) is a subcutaneously administered single-domain antibody against PD-L1 and has the potential to restore virus-specific immune responses in patients with chronic viral infection


Glenmark receives tentative ANDA approval for Calcipotriene and Betamethasone Dipropionate
Drug Approval | May 09, 2022

Glenmark receives tentative ANDA approval for Calcipotriene and Betamethasone Dipropionate

Glenmark's current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 48 ANDA's pending approval with the USFDA