Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 54

Results For "approval"

2475 News Found

Zydus receives final approval from USFDA for Topiramate Extended-Release capsules
Drug Approval | December 02, 2022

Zydus receives final approval from USFDA for Topiramate Extended-Release capsules

Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)


JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets
Drug Approval | December 01, 2022

JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets

This product is based on Osmotic Controlled Release Oral Delivery System technology


AstraZeneca’s Dapagliflozin receives CDSCO approval
Drug Approval | November 30, 2022

AstraZeneca’s Dapagliflozin receives CDSCO approval

Dapagliflozin reduces the risk of sustained eGFR, cardiovascular deaths and hospitalization for heart failure in adults with CKD


Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection
Drug Approval | November 29, 2022

Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection

The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India


Zydus receives final approval from USFDA for Famotidine Injection
News | November 24, 2022

Zydus receives final approval from USFDA for Famotidine Injection

Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed


Alembic receives USFDA final approval for Nifedipine Extended-Release Tablets
Drug Approval | November 22, 2022

Alembic receives USFDA final approval for Nifedipine Extended-Release Tablets

Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022


USFDA completes pre-approval inspection of BHL's Vadodara facility
Drug Approval | November 21, 2022

USFDA completes pre-approval inspection of BHL's Vadodara facility

The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited


Strides receives USFDA approval for Potassium Chloride Oral Solution
Drug Approval | November 19, 2022

Strides receives USFDA approval for Potassium Chloride Oral Solution

The approval further strengthens the Potassium Chloride franchise for the company.


Eugia Pharma receives USFDA approval for Amphotericin B Liposome for Injection
Drug Approval | November 19, 2022

Eugia Pharma receives USFDA approval for Amphotericin B Liposome for Injection

The product is expected to be launched by Q4 FY23.


Alembic receives USFDA final approval for Cyclophosphamide Capsules
Drug Approval | November 14, 2022

Alembic receives USFDA final approval for Cyclophosphamide Capsules

Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.