USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

The observations issued are neither repeated observations nor related to data integrity

Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure

Syensqo partners with MezLight to launch the world’s first sterile reusable surgical task light

Novel illumination system with key components molded in Radel® PPSU for durability and repeated sterilization

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles

Akums commissions new manufacturing facility for Lyophilized and Sterile dosage

The facility is equipped with state-of-the-art technology to produce high-quality lyophilized (freeze-dried) products

Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion

Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery

Piramal Pharma Solutions announces US$ 80 million expansion plan for Sterile Injectables facility in Kentucky

Briefs: Eugia Steriles and Shelter Pharma

Eugia Steriles receives EIR from USFDA for new injectable facility

ANVISA completes inspection at Caplin Steriles' facility at Gummidipoondi

Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP

Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension