Medical Dialogues
  • Dermatology
Sign in Signup
This site is intended for healthcare professionals only
Sign in Signup
  • Medical Jobs
  • Medical Matrimony
  • MD Brand Connect
  • MDTV
Medical Dialogues
  • Medical News
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • MCI News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Medical Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Aborad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
  • MDTV
      • Anesthesia
      • CTVS
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • Diet and nutrition
      • ENT
      • Gastroenterology
      • Health Dialogues
      • Health News today
      • Health Shorts
      • Health Updates
      • Health video of the day
      • Laboratory Medicine
      • Latest Videos
      • Latest Webinars
      • MD shorts
      • Medical News Today
      • Medical Updates
      • Medical Video of the day
      • Medicine
      • Nephrology
      • Neurology and Neurosurgery
      • Obstetrics and Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics & Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Top Videos
      • Urology
This site is intended for healthcare professionals only
Sign InRegister
Medical Dialogues
Sign inRegister
  • Home
  • Medical news
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • MCI News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Medical Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Aborad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
  • Case of the Day
  • Editorial
  • Home
  • News
  • Industry
  • Pharma News
  • Import ban on Ipca...

Import ban on Ipca Labs API for chloroquine phosphate reinforced by USFDA

ruchikaBy ruchikaPublished On 2020-06-25T13:00:53+05:30  |  Updated On 2020-06-25T12:57:10+05:30
Import ban on Ipca Labs API for chloroquine phosphate reinforced by USFDA

In a regulatory filing Ipca Laboratories said, the US Food and Drug Administration (USFDA) has informed the company that the "shortage implications for chloroquine phosphate API has changed and chloroquine phosphate drug product is no longer in shortage and therefore, no shipment of API chloroquine phosphate will be excluded from the import alert."

New Delhi: Ipca Laboratories on Wednesday said the US health regulator has removed the partial lifting of import alert on its active pharmaceuticals ingredients (APIs) manufacturing facility situated at Ratlam, in Madhya Pradesh with no shortage of Chloroquine Phosphate drug in the US.In a regulatory filing Ipca Laboratories said, the US Food and Drug Administration (USFDA) has informed...

New Delhi: Ipca Laboratories on Wednesday said the US health regulator has removed the partial lifting of import alert on its active pharmaceuticals ingredients (APIs) manufacturing facility situated at Ratlam, in Madhya Pradesh with no shortage of Chloroquine Phosphate drug in the US.

In a regulatory filing Ipca Laboratories said, the US Food and Drug Administration (USFDA) has informed the company that the "shortage implications for chloroquine phosphate API has changed and chloroquine phosphate drug product is no longer in shortage and therefore, no shipment of API chloroquine phosphate will be excluded from the import alert."

USFDA has also informed that due to potential shortage implications and/or medical necessity, an exception to the import alert was made for API Hydroxychloroquine Sulfate and "this exception will be re-considered if the shortage implications change," the filing added.

In March, USFDA had partially lifted import alert imposed on the company's API plant at Ratlam and formulations units at Pithampur in the same state and Piparia in Silvassa, allowing shipments of hydroxychloroquine sulphate and chloroquine phosphate APIs; and hydroxychloroquine sulphate tablets produced at these facilities to the US.

However, the exception was subject to reconsideration if the shortage implications changed, USFDA had said.

Due to violation of good manufacturing practices (GMPs)as per the USFDA norm, the company's plants have been under import alert, under which the regulator has the right for detention without physical examination of drugs from firms that have not met the GMPs.

Read also: Ipca Labs net profit falls 13.5 pc at Rs 83 crore in Q4

ipca labs ipca labs news chloroquine phosphate drug usfda hydroxychloroquine sulfate 
Source : PTI
ruchika
ruchika

    Ruchika joined Medical Dialogue an Desk Editor for the Business Section in 2019. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate from Delhi University. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Show Full Article
    Next Story
    Similar Posts
    NO DATA FOUND

    Editorial

    Air pollution and allergic rhinitis: Understanding the invisible, yet the inevitable  connection

    Air pollution and allergic rhinitis: Understanding the invisible, yet the inevitable connection

    Treatment challenges in managing Gastroparesis related to PPI Use: Analyzing scope of Probiotics

    Treatment challenges in managing Gastroparesis related to PPI Use: Analyzing scope of Probiotics

    Review: Efficacy of Antiviral Agents Against  Omicron Subvariant BA.2

    Review: Efficacy of Antiviral Agents Against Omicron Subvariant BA.2

    Choice of Antibiotics in Common Infections: Doxycycline or Azithromycin?

    Choice of Antibiotics in Common Infections: Doxycycline or Azithromycin?

    Role of acyclovir in Management of chickenpox: Analyzing the importance of starting early

    Role of acyclovir in Management of chickenpox: Analyzing the importance of starting early

    View All

    Journal Club Today

    Women who embraced their partner to have lower stress-induced cortisol response

    Women who embraced their partner to have lower stress-induced cortisol response

    View All

    Health News Today

    Health Bulletin 20/May/2022

    Health Bulletin 20/May/2022

    View All
    © 2019 All Rights Reserved.
    Powered By: Hocalwire
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok
    X
    X