Quick access to main page (top) Direct access to main contents Quick access to main page (bottom)

SCD Pharm’s Ophthalmic Drug Approved by FDA: U.S. Market Entry Imminent

inews24 Views  

Anticipated to Reach 70% of Third-Quarter Operating Profit Goal

SamChunDang (SCD) Pharm announced on the 18th that it had received product import approval from the U.S. Food and Drug Administration (FDA) on the evening of the 17th from its U.S. generic ophthalmic drug partner.

SamChunDang (SCD) Pharm [Photo=SCD Pharm]

After signing a supply contract for ophthalmic drugs with its U.S. partner, SCD Pharm has been pursuing development and approval applications for several years. The import approval was confirmed to be for the ophthalmic drug for glaucoma treatment, the first product submitted for approval.

A company representative explained, “The import approval is a procedure called PLAIR (Pre-Launch Activities Importation Requests), which approves the import of products before issuing a permit from the FDA. We expect the product approval to be issued in the near future.”

The representative continued, “SCD Pharm has already completed production in response to pre-orders from partners anticipating product approval and will be able to export to the U.S. on May 10th after quality control (QC) testing is completed. This is the first time a Korean company is exporting generic ophthalmic drugs to the U.S. market, and we expect to achieve our initial operating profit target of 70% in the third quarter.”

The sterile ophthalmic drug market is known as a high-profit niche market with few competitors despite the complexity of development. SCD Pharm has reaped the benefits of years of development. Although the approval process was slightly delayed due to the unexpected variable of the COVID-19 pandemic, the approval process for ophthalmic drugs has accelerated after the sterile ophthalmic drug facility passed the FDA inspection. The company expects a steady stream of product approvals and exports to begin this year.

A company representative said, “We expect that this export will accelerate negotiations for additional ophthalmic drug contracts with our partners. Once contracts are signed, we will announce them through public disclosures and the media.”

SC” Pharm has signed supply contracts for 14 generic ophthalmic drug products with partners in the U.S. and is proceeding with the approval process with them. They recently applied for product approval for the world’s Eylea biosimilar PFS·Vial.

inews24
content@viewusglobal.com

Comments0

300

Comments0

[BUSINESS] Latest Stories

  • Honda's NSX Returns: A 1,000-Horsepower Electric Rival to Lexus LFR
  • Honda’s S7 Electric SUV: A Major Player in the Race for EV Dominance
  • Lamborghini's First EV: A 2,000-Horsepower Beast Built for Speed and Emotion
  • Ford Revives Classic Design with the 2025 Bronco Heritage Edition
  • ID.EVERY1: Volkswagen's $21K Electric Vehicle Aims to Make Green Driving Accessible
  • Toyota’s bZ3X SUV Surges with 10,000 Pre-Orders: A New Era in EVs

You May Also Like

  • 1
    Boiling or Raw? The Shocking Truth About Which Veggies You Should Never Cook

    LIFESTYLE 

  • 2
    Family History of Diabetes? Here’s How to Take Control!

    LIFESTYLE 

  • 3
    4 Hormones That Can Actually Make You Happier

    LIFESTYLE 

  • 4
    Traditional African Foods Slash Inflammation—While Western Diets Fuel It

    LIFESTYLE 

  • 5
    Could Ozempic Help Your Brain? GLP-1 Drugs Linked to Lower Dementia Risk

    LIFESTYLE 

Popular Now

  • 1
    New Warning: Antidepressants Could Increase Risk of Fatal Heart Event

    LIFESTYLE 

  • 2
    Just Two Days of Intense Exercise Could Slash Your Risk of Death

    LIFESTYLE 

  • 3
    4:3 Fasting Helps Shed More Pounds Than Daily Dieting, Says New Study

    LIFESTYLE 

  • 4
    This Study Says Winter-Conceived Babies May Grow Up Leaner—Here’s Why

    LIFESTYLE 

  • 5
    Harvard Reveals 7 Easy Chair Exercises That Are Surprisingly Powerful for Seniors

    LIFESTYLE 

Must-Reads

  • 1
    Boiling or Raw? The Shocking Truth About Which Veggies You Should Never Cook

    LIFESTYLE 

  • 2
    Family History of Diabetes? Here’s How to Take Control!

    LIFESTYLE 

  • 3
    4 Hormones That Can Actually Make You Happier

    LIFESTYLE 

  • 4
    Traditional African Foods Slash Inflammation—While Western Diets Fuel It

    LIFESTYLE 

  • 5
    Could Ozempic Help Your Brain? GLP-1 Drugs Linked to Lower Dementia Risk

    LIFESTYLE 

Popular Now

  • 1
    New Warning: Antidepressants Could Increase Risk of Fatal Heart Event

    LIFESTYLE 

  • 2
    Just Two Days of Intense Exercise Could Slash Your Risk of Death

    LIFESTYLE 

  • 3
    4:3 Fasting Helps Shed More Pounds Than Daily Dieting, Says New Study

    LIFESTYLE 

  • 4
    This Study Says Winter-Conceived Babies May Grow Up Leaner—Here’s Why

    LIFESTYLE 

  • 5
    Harvard Reveals 7 Easy Chair Exercises That Are Surprisingly Powerful for Seniors

    LIFESTYLE 

Share it on...