• Contact us
  • Advertise with us
  • Login
Tashi Pharma
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • All
    • EDQM
    • EMA
    • European Commision
    • Health Canada
    • Medsafe
    • MHRA
    • SAHPRA
    • US FDA
    FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

    FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

    Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

    US FDA publishes guidance on Initiation of Voluntary Recalls

    EMA publishes Q & A for Bootstrap methodology for f2 similarity factor

    EMA publishes Q & A on Bootstrap methodology for f2 similarity factor

    US FDA publishes product-specific guidances to facilitate generic drug development

    US FDA publishes product-specific guidances to facilitate generic drug development

    Clinical Trials Regulation comes into effect in the EU

    New Clinical Trials Regulation comes into effect in the EU

    Reflection paper Forecasting demand for medicinal products in the EU_EEA

    EMA publishes reflection paper on forecasting demand for medicinal products in the EU/EEA

    Trending Tags

    • Pharma
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • Clinical
    • bioanalytical
  • Webinar
No Result
View All Result
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • All
    • EDQM
    • EMA
    • European Commision
    • Health Canada
    • Medsafe
    • MHRA
    • SAHPRA
    • US FDA
    FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

    FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

    Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

    US FDA publishes guidance on Initiation of Voluntary Recalls

    EMA publishes Q & A for Bootstrap methodology for f2 similarity factor

    EMA publishes Q & A on Bootstrap methodology for f2 similarity factor

    US FDA publishes product-specific guidances to facilitate generic drug development

    US FDA publishes product-specific guidances to facilitate generic drug development

    Clinical Trials Regulation comes into effect in the EU

    New Clinical Trials Regulation comes into effect in the EU

    Reflection paper Forecasting demand for medicinal products in the EU_EEA

    EMA publishes reflection paper on forecasting demand for medicinal products in the EU/EEA

    Trending Tags

    • Pharma
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • Clinical
    • bioanalytical
  • Webinar
No Result
View All Result
No Result
View All Result
Home Indian Pharma News

Zydus and TLC sign agreement to market Liposomal Amphotericin B in India

PRN by PRN
May 26, 2021
in Indian Pharma News
44 2
0
Zydus and TLC sign agreement to market Liposomal Amphotericin B, a critical drug to treat Black Fungus or Mucormycosis in India

representative image

29
SHARES
70
VIEWS

Zydus and TLC, a specialty pharmaceutical company in Taiwan, today announced the signing of a license supply and commercialization agreement to commercialize AmphoTLC™ (Amphotericin B Liposome for Injection 50mg) in India. AmphoTLC™ is a critical drug to treat Mucormycosis or Black Fungus in India. Under the terms of the agreement, TLC will manufacture and supply AmphoTLC™ on a non-exclusive basis to Zydus, and Zydus will commercialize AmphoTLC™ in India.

The Central Drugs Standard Control Organization (CDSCO) of India has approved the New Drug Application (NDA) of TLC for Amphotericin B Liposome for Injection 50mg or AmphoTLC™ for immediate importation as per approved usage and indication. AmphoTLC™ is the first and only complex generic drug to have achieved bioequivalence to Gilead’s AmBisome, proving its sameness to the safest form of amphotericin B in the world. With the surge of infections in India in the recent days AmphoTLC™ will address the country’s acute liposomal amphotericin B shortage.

AmphoTLC is a liposomal amphotericin B injection indicated for severe systemic fungal infections such as mucormycosis. The drug is approved in Taiwan and has been manufactured and sold by Yung Shin Pharmaceutical Industrial Co. (YSP) for several years. The approval of AmphoTLC™ in India follows the conduct of comprehensive due diligence by regulators in India based on the numerous years of development TLC has dedicated as well as its quality performance in the developed markets.

Speaking on the development, Dr. Sharvil Patel, Managing Director, of Cadila Healthcare Ltd, said, “With India facing an acute shortage of the drug to treat mucormycosis, we are making this critical drug available in India on an immediate basis. The need of the hour is to tackle this life-threatening infection with a safe and effective therapy.”

Commenting on the speed of the process, George Yeh, President of TLC, said, “We would like to thank Zydus for their quick action and cooperation in enabling a swift commercialization process. TLC is glad to be able to assist in the humanitarian crisis in such a quick fashion, and as our corporate tagline – Delivering Hope for Life™ – depicts, we will be delivering the first batch of AmphoTLC™ to India to help assuage the urgent need for one of the safest and most effective antifungal drugs very soon.”

Tags: zydus
Previous Post

Boehringer Ingelheim’s drug receives FDA Breakthrough Therapy Designation

Next Post

Orion to investigate possible sale of its pharmaceutical manufacturing plant in Kuopio, Finland

PRN

PRN

Related Posts

Zydus to launch Oxemia
Indian Pharma News

Zydus to launch Oxemia (Desidustat) a treatment for Anemia in patients with Chronic Kidney Disease (CKD)

by admin
March 7, 2022
FDA Urges Companies to be 'Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls
Indian Pharma News

US FDA Urges Companies to be ’Recall Ready’ to Protect Public Health

by admin
March 6, 2022
Kilitch Drugs Commences Rs. 100 Crore New Facility Expansion Plan
Indian Pharma News

Kilitch Drugs Commences Rs. 100 Crore New Facility Expansion Plan

by admin
March 5, 2022
Themis Medicare receives approval for immunomodulatory antiviral drug from DCGI
Indian Pharma News

Themis Medicare receives approval for immunomodulatory antiviral drug from DCGI

by admin
March 4, 2022
Lupin Receives Approval from U.S. FDA for Efinaconazole Topical Solution
Indian Pharma News

Lupin Receives Approval from U.S. FDA for Efinaconazole Topical Solution

by admin
March 3, 2022
Next Post
Orion to investigate possible sale of its pharmaceutical manufacturing plant in Kuopio, Finland

Orion to investigate possible sale of its pharmaceutical manufacturing plant in Kuopio, Finland

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Recent News

Zydus to launch Oxemia

Zydus to launch Oxemia (Desidustat) a treatment for Anemia in patients with Chronic Kidney Disease (CKD)

March 7, 2022
FDA Urges Companies to be 'Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

US FDA Urges Companies to be ’Recall Ready’ to Protect Public Health

March 6, 2022
FDA Clinical Trial Guidances for Advancing Development of Cancer Treatments

FDA publishes Clinical Trial Guidances for Advancing Development of Cancer Treatments

March 5, 2022
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

US FDA publishes guidance on Initiation of Voluntary Recalls

March 5, 2022
Kilitch Drugs Commences Rs. 100 Crore New Facility Expansion Plan

Kilitch Drugs Commences Rs. 100 Crore New Facility Expansion Plan

March 5, 2022

Browse by Category

  • Articles
  • Company Focus
  • EDQM
  • EMA
  • European Commision
  • Global Pharma News
  • Guideline News
  • Health Canada
  • Indian Pharma News
  • Interview
  • Medsafe
  • MHRA
  • SAHPRA
  • US FDA
  • Webinar

Browse by Tags

Abbott Alembic alkem Amgen Amneal AstraZeneca bayer biocon Biogen BioNTech Bristol Myers Squibb cipla covid Daiichi Sankyo drreddy Eli Lilly fda Gilead glenmark gsk Incyte Janssen Jubilant lupin MHRA Moderna Natco Novartis Novavax novo nordisk oncology Panacea Biotech Pfizer pharmacy Pharma News Pharmareg News Remdesivir roche sanofi Sun pharma Teva usfda Vaccine Viatris zydus

Contact us

Address:Pharma Reg News, First floor, Shop no.1 , Plot no 241,242, Near Fire station, GIDC, Ankleshwar, Gujarat - 393002.
Phone:+91 8511586232, +91 9029066605
Email:author@pharmaregnews.com

Browse by Tag

Abbott Alembic alkem Amgen Amneal AstraZeneca bayer biocon Biogen BioNTech Bristol Myers Squibb cipla covid Daiichi Sankyo drreddy Eli Lilly fda Gilead glenmark gsk Incyte Janssen Jubilant lupin MHRA Moderna Natco Novartis Novavax novo nordisk oncology Panacea Biotech Pfizer pharmacy Pharma News Pharmareg News Remdesivir roche sanofi Sun pharma Teva usfda Vaccine Viatris zydus

Advertise with us

© 2021 - Pharmaregnews.com. Developed by YESWEUS.

No Result
View All Result
  • Home
  • Indian Pharma News
  • Global Pharma News
  • Guideline News
    • EMA
    • MHRA
    • TGA
    • US FDA
  • Articles
  • Interview
  • Company Focus
  • Pharma Jobs
    • Quality
    • Regulatory Affairs
    • Production
    • Sales and Marketing
    • bioanalytical
    • Clinical
  • Webinar
  • Contact us
  • Advertise with us
  • Login

© 2021 - Pharmaregnews.com. Developed by YESWEUS.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In
Are you sure want to unlock this post?
Unlock left : 0
Are you sure want to cancel subscription?