CLOSE

Specials

I agree We use cookies on this website to enhance your user experience. By clicking any link on this page you are giving your consent for us to set cookies. More info

Skip to: Curated Story Group 1
lifesciencesreview
US
EUROPE
APAC
CANADA
  • US
    • US
    • EUROPE
    • APAC
    • CANADA
    • LATAM
  • Home
  • Contributors
  • News
  • Conferences
  • Newsletter
  • Whitepapers
  • Magazine
×
#

Life Science Review Weekly Brief

Be first to read the latest tech news, Industry Leader's Insights, and CIO interviews of medium and large enterprises exclusively from Life Science Review

Subscribe

loading

Thank you for Subscribing to Life Science Review Weekly Brief

  • Home
  • News

Recommended picks

Key Biotech Applications In Agriculture

Key Biotech Applications In Agriculture

Here's The List Of Top Biotech Stocks To Buy In 2022

Here's The List Of Top Biotech Stocks...

How Does Biotechnology Help Humans?

How Does Biotechnology Help Humans?

How Does Biotechnology Help Agriculture Sector Reap Benefits

How Does Biotechnology Help...

Tryp Therapeutics Breaks New Grounds in Investigational Drugs

Tryp Therapeutics Breaks New Grounds...

Biotechnology in Agriculture: Key Applications and Significance to Know

Biotechnology in Agriculture: Key...

DNA Sequencing Everything You Need to Know

DNA Sequencing Everything You Need to...

The Applications of Data Analytics in Biotechnology

The Applications of Data Analytics in...

Key Biotech Applications In Agriculture

Key Biotech Applications In Agriculture

Here's The List Of Top Biotech Stocks To Buy In 2022

Here's The List Of Top Biotech Stocks...

How Does Biotechnology Help Humans?

How Does Biotechnology Help Humans?

How Does Biotechnology Help Agriculture Sector Reap Benefits

How Does Biotechnology Help...

Tryp Therapeutics Breaks New Grounds in Investigational Drugs

Tryp Therapeutics Breaks New Grounds...

Biotechnology in Agriculture: Key Applications and Significance to Know

Biotechnology in Agriculture: Key...

DNA Sequencing Everything You Need to Know

DNA Sequencing Everything You Need to...

The Applications of Data Analytics in Biotechnology

The Applications of Data Analytics in...

FDA Approves Pacira Bioscience's EXPAREL Manufacturing Process

Life Sciences Review Life Sciences Review | Monday, August 09, 2021
Tweet

FDA approves Pacira’s Exparel manufacturing process to meet its growing demand for pain management.


FREMONT, CA: Pacira BioSciences announces that FDA has approved its enhanced manufacturing process for EXPAREL® (bupivacaine liposome injectable suspension), which is housed at a custom facility in Swindon, England, under a partnership with Thermo Fisher Scientific Pharma Services. The company is expected to start selling commercial products manufactured in this 200-liter suite by the end of 2021.


“This FDA approval underscores the quality assurance of our enhanced manufacturing process, which is essential as we scale the production of EXPAREL,” said Dave Stack, chairman, and chief executive officer of Pacira BioSciences. “Launching this new manufacturing site marks an important milestone for Pacira that will allow us to double our capacity to meet the growing demand for EXPAREL, while simultaneously improving our gross margins and extending our market exclusivity into 2041.”


In June 2021, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,033,495 related to EXPAREL. 


The patent, Manufacturing of Bupivacaine Multi vesicular Liposomes, claims composition of EXPAREL prepared by the improved manufacturing process and has an expiration date of January 22, 2041. Pacira submitted this patent for listing in the FDA's Approved “Drug Products with Therapeutic Equivalence Evaluations” (the Orange Book) in July 2021.


Pacira BioSciences is the industry leader in its commitment to non-opioid pain management and regenerative health solutions to improve patient’s journey along the neural pain pathway.


EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients six years of age and above for single-dose infiltration to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. A single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption.


Weekly Brief

loading
Top 10 Leading BioTech Solution Companies - 2021
> <
  • Regulatory Services 2023

    Top Vendors

    Current Issue
  • Clinical Lab Equipment 2023

    Top Vendors

    Current Issue
  • Regulatory Services 2023

    Top Vendors

    Current Issue
  • Clinical Lab Equipment 2023

    Top Vendors

    Current Issue

Read Also

Prophesying DNA Sequencing for 2023

Crucial Workflows of Next-Generation Sequencing

An Overview of Next-Generation Sequencing

The Role of AI in Accurate Medical Writing

Patrik Renblad to Join Cantargia as Chief Financial Officer

Overview of the Life Sciences BPO Market

Dr. Zamaneh Mikhak Joins TFF Pharmaceutical as the New Chief Medical Officer

The Significance of AI in Medical Writing

Loading...

Copyright © 2023 Life Sciences Review . All rights reserved. |  Subscribe |  About Us follow on linkedin

This content is copyright protected

However, if you would like to share the information in this article, you may use the link below:

https://www.lifesciencesreview.com/news/fda-approves-pacira-bioscience-s-exparel-manufacturing-process-nwid-493.html