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Results For "US-FDA"

251 News Found

Syngene Q2 FY23-24 revenue from operations up 18.5% to Rs 910 Cr
News | October 18, 2023

Syngene Q2 FY23-24 revenue from operations up 18.5% to Rs 910 Cr

Profit after tax (before exceptional items) up 23% to Rs 215 crores


Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart
Drug Approval | October 09, 2023

Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart

The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022


Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals
News | October 03, 2023

Briefs: Aurobindo Pharma and Balaxi Pharmaceuticals

Balaxi Healthcare Ecuador S.A.S. has become a Wholly Owned Subsidiary of the company


SigTuple’s AI100 with Shonit receives USFDA 510(k) clearance
Startup | October 03, 2023

SigTuple’s AI100 with Shonit receives USFDA 510(k) clearance

SigTuple’s AI100 with Shonit is the premier solution for AI assisted digital pathology


Briefs: Caplin Steriles, Zydus  and APL Healthcare
Drug Approval | September 20, 2023

Briefs: Caplin Steriles, Zydus and APL Healthcare

Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients


Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma
News | September 08, 2023

Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma

Strides Pharma Science Limited to acquire 100% in Strides Pharma Services Pvt Ltd.


Biocon acquires oral solid dosage manufacturing facility of Eywa Pharma for US$7.7 million
News | September 02, 2023

Biocon acquires oral solid dosage manufacturing facility of Eywa Pharma for US$7.7 million

The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year


Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules
Drug Approval | August 31, 2023

Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules

Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR


Gland Pharma receives 2 observations under 483 for Pashamylaram facility
News | August 28, 2023

Gland Pharma receives 2 observations under 483 for Pashamylaram facility

The company is committed to address the observations and will submit its response to US FDA within the stipulated time