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3397 News Found

Innoxel Lifesciences completes USFDA inspection
Drug Approval | May 06, 2025

Innoxel Lifesciences completes USFDA inspection

This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence


Roquette completes acquisition of IFF Pharma Solutions
News | May 05, 2025

Roquette completes acquisition of IFF Pharma Solutions

The transaction enhances Roquette’s ability to deliver high-value drug delivery solutions to pharmaceutical customers worldwide


Alembic receives USFDA final approval for Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg
Drug Approval | May 03, 2025

Alembic receives USFDA final approval for Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg

Ticagrelor tablets are indicated for to reduce the risk of cardiovascular death and myocardial infarction,


Neuland Laboratories completes USFDA inspection at Unit 2
Drug Approval | May 03, 2025

Neuland Laboratories completes USFDA inspection at Unit 2

The FDA issued Form 483 with one observation related to building and facility management


Zydus receives final approval from USFDA for Niacin Extended-Release Tablets USP
Drug Approval | May 02, 2025

Zydus receives final approval from USFDA for Niacin Extended-Release Tablets USP

Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides (TG)


Sigachi Industries signs MoU with Respilon Group
News | May 01, 2025

Sigachi Industries signs MoU with Respilon Group

This partnership marks a significant milestone in Sigachi's strategy to expand into advanced drug delivery technologies.


Strides receives USFDA approval for anti-inflammatory Celecoxib Capsules
Drug Approval | May 01, 2025

Strides receives USFDA approval for anti-inflammatory Celecoxib Capsules

Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base


CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings
Clinical Trials | May 01, 2025

CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings

Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings


Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution
Drug Approval | May 01, 2025

Gland Pharma receives USFDA approval for Latanoprostene Bunod Ophthalmic Solution

This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension


IOL Chemicals and Pharmaceuticals receives approval CDE of NMPA, China for Ibuprofen
Drug Approval | April 29, 2025

IOL Chemicals and Pharmaceuticals receives approval CDE of NMPA, China for Ibuprofen

This approval authorizes the company to export Ibuprofen to the Chinese markets