Remove Containment Remove Drug Delivery Systems Remove Production
article thumbnail

FDA Warns of Dosing Errors with Compounded Semaglutide Injectables

XTalks

The FDA has issued a warning about dosing errors and subsequent adverse events related to compounded semaglutide injectable products. These issues primarily stem from patients and healthcare providers miscalculating or incorrectly administering the drug. These errors have led to some patients being hospitalized due to overdoses.

article thumbnail

Shift in the trend of Container closure integrity testing

Roots Analysis

In earlier times, container closure integrity testing was not regarded as an essential step in the process of manufacturing. The company developing drug product through such an intense process, use to consider container closure system only for packaging of the product. [1]

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Leading commercial dose (non-sterile) companies in contract marketing

Pharmaceutical Technology

The production of commercial dose non-sterile products such as tablets, capsules, ointments, creams, and powders is rising due to their growing global demand, attributed to increasing demand for anti-ageing products, hereditary factors, genetic mutations, exposure to harmful radiation, and rising geriatric population.

Marketing 100
article thumbnail

Mitigating the risks of cross-contamination during Oral Solid Dose (OSD) manufacturing

Pharmaceutical Technology

While the industry is seeing advances in alternative drug delivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry. This heightens the risk of cross contamination, requiring effective containment solutions, especially when handling highly potent powders.

article thumbnail

Hydrocortisone by Antares Pharma for Adrenal Insufficiency: Likelihood of Approval

Pharmaceutical Technology

Antares Pharma overview Antares Pharma is a specialty pharmaceutical company engaged in the development, manufacturing, and commercialization of pharmaceutical products and technologies. It also develops products to reduce the risk of preterm birth in pregnant women.

article thumbnail

Flexible grinding processes for sterile nanopharmaceutical manufacturing

Pharmaceutical Technology

It indicates that nanomedicine also has the potential to combat the threat of antibiotic resistance via the use of nanomaterials with intrinsic antibacterial properties, as well as using nanoparticles as effective drug delivery systems for antibacterial agents.

article thumbnail

Scrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents

FDA Law Blog

As we explained back in March , Teva had initiated Hatch-Waxman pre-launch patent litigation against Amneal for infringement of 5 Orange Book-listed patents reading on the device constituent (a metered dose inhaler) of Teva’s combination product ProAir HFA. b)(1) that drug product patents may be listed if they claim the “drug product.