News about "USFDA"

Terumo BCT Receives FDA Clearance for Innovative Rika Plasma Donation System with iNomi Nomogram

Terumo BCT Receives FDA Clearance for Innovative Rika Plasma Donation System with iNomi Nomogram

This development marks a key advancement in plasma collection technology, allowing for the determination of plasma collection volume based on an individual donor's height, weight, and hematocrit level at the time of donation.

USFDA | 13/05/2024 | By Abha

4C Medical's AltaValve System Granted Breakthrough Device Designation by FDA

4C Medical's AltaValve System Granted Breakthrough Device Designation by FDA

The FDA has granted the AltaValve System Breakthrough Device designations for two therapeutic indications.

USFDA | 09/05/2024 | By Abha

Single Pass Receives FDA Clearance for Kronos Biopsy Closure Device

Single Pass Receives FDA Clearance for Kronos Biopsy Closure Device

Under the leadership of Bill Colone and the Board of Directors, the Single Pass team collaborated with their contract manufacturing partner, M4D, located in Lake Forest, CA, to bring the Kronos device to market. 

USFDA | 30/04/2024 | By Abha

Gland Pharma Receives USFDA Approval for Cetrorelix Acetate Injection

Gland Pharma Receives USFDA Approval for Cetrorelix Acetate Injection

According to IQVIA, the product had US sales of approximately USD 129 million for the twelve months ending February 2024.

USFDA | 29/04/2024 | By Abha

Piramal Alternatives Announces Investment of INR 110 Crore in Biodeal

Piramal Alternatives Announces Investment of INR 110 Crore in Biodeal

Piramal Alternatives has made a significant investment of INR 110 Crore in Biodeal Pharmaceuticals Ltd., a leading contract development and manufacturing company, facilitated through convertible instruments from its Performing Credit Fund.

USFDA | 08/04/2024 | By Aishwarya

Ajanta Pharma Receives Final Approval for Topiramate Extended Release Capsules from USFDA

Ajanta Pharma Receives Final Approval for Topiramate Extended Release Capsules from USFDA

The company has received 50 final ANDA approvals, out of which 41 are commercialized.

USFDA | 31/08/2023 | By Manvi 254

Glenmark Pharmaceuticals in Process of Recalling 1,200 Bottles of Subpotent Hypertension Drug in USA

Glenmark Pharmaceuticals in Process of Recalling 1,200 Bottles of Subpotent Hypertension Drug in USA

The affected lot has been manufactured at the Goa plant of the Mumbai-based drug firm and then supplied to Glenmark Pharmaceuticals Inc, USA, the USFDA said.

USFDA | 29/08/2023 | By Manvi 202

USFDA Conducts Pre-Market Inspection at Pashamylaram Facility of Gland Pharma

USFDA Conducts Pre-Market Inspection at Pashamylaram Facility of Gland Pharma

The Company is committed to address the observations and will submit its response to USFDA within the stipulated time.

USFDA | 28/08/2023 | By Manvi 261

Gland Pharma Receives EIR From USFDA For Dundigal Facility

Gland Pharma Receives EIR From USFDA For Dundigal Facility

Gland Pharma shares gained nearly 3 percent in trade after receiving EIR.

USFDA | 25/08/2023 | By Manvi 303

Aurisco's Manufacturing Site in China Clears FDA Inspection

Aurisco's Manufacturing Site in China Clears FDA Inspection

Aurisco's Manufacturing Site in China Clears FDA Inspection

USFDA | 24/08/2023 | By Sudeep Soparkar 193


 

 

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