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Packaging Solutions for Pharmaceuticals & Medical Devices: Insights and Considerations

XTalks

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. Container Closure Systems. extractables and leachables).

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Medical Device Packaging Regulations

Pharma Packaging Solutions

As a premier provider of medical device packaging solutions, we recognize the prime importance of adhering to global regulations while creating packaging solutions that protect both products and patients. Essential Packaging Requirements Examining the arena of packaging requirements reveals many considerations.

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MIOTIFY platform for digital health products clears AZ road test

pharmaphorum

UK company MIOTIFY has developed a web-based software platform that product teams can use to configure medical algorithms quickly, create code packages to harness them and generate supporting documentation – all in a format that is designed to meet regulatory requirements for software as a medical device (SaMD).

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Health Highlights, Dec. 10, 2020

The Pharma Data

. “This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in an agency news release. © 2020 HealthDay. All rights reserved. Posted: December 2020.

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A USD 4.2 Billion Myovant/ Pfizer Deal; Audentes Therapeutics’ ASPIRO Trial Free to Proceed; First Generic of Drug for Severe Hypoglycemia Gets Approval; Teleflex Acquires Z-Medica

Delveinsight

Food and Drug Administration has given a green signal to the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia. . Teleflex Incorporated has finally completed the acquisition of Z-Medica, an industry-leading manufacturer of hemostatic products.

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Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19

The Pharma Data

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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Prefilled Syringes: Delivering Convenience and Precision in Every Dose

Roots Analysis

Notably, the integration of autoinjectors with prefilled syringe provides a user-friendly and convenient drug delivery product; examples of such products include Companion® Staked Needle Syringe ( Credence MedSystems ), Gx® Prefillable Luer Lock Glass Syringe ( Gerresheimer ) and syriQ Staked Needle Syringe ( SCHOTT AG ).