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Results For "manufacturing-facility"

631 News Found

Briefs: Biocon, Laurus Labs and Smruthi Organics
Drug Approval | February 13, 2023

Briefs: Biocon, Laurus Labs and Smruthi Organics

Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.


JB Pharma records revenue growth of 32% to Rs. 793 Cr in Q3 FY23
News | February 09, 2023

JB Pharma records revenue growth of 32% to Rs. 793 Cr in Q3 FY23

Profit after Tax stood at Rs. 106 crore as compared to Rs. 84 crore registering growth of 26%


Balaxi Pharmaceuticals revenue up 40.3%
News | February 02, 2023

Balaxi Pharmaceuticals revenue up 40.3%

During the quarter, foreign exchange fluctuations had an impact of Rs. 4.56 crore Q3 FY23 Profit After Tax after considering exchange rate fluctuations stood at Rs. 8.2 crore


USFDA inspection: Zydus Lifesciences and Gland Pharma
Drug Approval | January 28, 2023

USFDA inspection: Zydus Lifesciences and Gland Pharma

The United States Food and Drug Administration (USFDA) conducted an inspection at Gland Pharma Limited API Facility at JNPC, Visakhapatnam


Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules
Drug Approval | January 25, 2023

Granules Pharmaceuticals receives ANDA approval for amphetamine mixed salts ER capsules

Granules now have a total of 53 ANDA approvals from USFDA


Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr
News | January 24, 2023

Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr

The company is pleased to report positive performances from all divisions this quarter. Growth in our research divisions, Discovery Services and the Dedicated Centres was solid


USFDA completes inspection at APL HealthCare
Drug Approval | January 19, 2023

USFDA completes inspection at APL HealthCare

The company has been issued ‘Form 483’ with two observations


Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules
Drug Approval | January 16, 2023

Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India


Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets
Drug Approval | January 13, 2023

Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults


Zydus receives final approval from the USFDA for Febuxostat Tablets
Drug Approval | January 10, 2023

Zydus receives final approval from the USFDA for Febuxostat Tablets

Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).