Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • Medical Jobs
  • Medical Matrimony
  • MD Brand Connect
  • 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
    • Medico Legal Update
    • Nephrology
    • Neurology and Neurosurgery
    • Obstetrics and Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics & Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Top Videos
    • Urology
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
    • Pharmacy Education 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
      • Medico Legal Update
      • 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
LoginRegister
Medical Dialogues
LoginRegister
  • 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
    • Pharmacy Education News
  • Case of the Day
  • Editorial
  • Home
  • News
  • Health News
  • Awaiting USFDA...

Awaiting USFDA response on remediation efforts of 3 units: Dr Reddys Laboratories

Written by savita thakur thakur Published On 2016-02-18T09:44:38+05:30  |  Updated On 18 Feb 2016 4:14 AM GMT
Awaiting USFDA response on remediation efforts of 3 units: Dr Reddys Laboratories
  • Facebook
  • Twitter
  • Whatsapp
  • Telegram
  • Linkedin
  • Email
  • koo
  • Facebook
  • Twitter
  • Whatsapp
  • Telegram
  • Linkedin
  • Email
  • koo
  • Facebook
  • Twitter
  • Whatsapp
  • Telegram
  • Linkedin
  • Email
  • koo

NEW DELHI: Dr Reddy's Laboratories (DRL) is awaiting a response from USFDA for future course of action over its three plants, for which the health regulator had issued warning letter, as the drug firm has completed its comprehensive corrective and preventive action plan (CAPA)."As of January 31, 2016 all the CAPA which were due for completion have been completed," DRL's COO Abhijit Mukherjee...

NEW DELHI: Dr Reddy's Laboratories (DRL) is awaiting a response from USFDA for future course of action over its three plants, for which the health regulator had issued warning letter, as the drug firm has completed its comprehensive corrective and preventive action plan (CAPA).

"As of January 31, 2016 all the CAPA which were due for completion have been completed," DRL's COO Abhijit Mukherjee told analysts.

He, however, did not share by when issues related to the three plants could be resolved saying, "on the remediation, we certainly cannot provide you any explanatory guidance on the timelines because on our side we are doing whatever we can to mitigate, workout on the CAPAs, update FDA and the overall journey, we think, is progressing satisfactorily. Beyond this (it) is completely the agency's prerogative."

The CAPA Plan includes site specific CAPA, manufacturing network-wide CAPA and CAPA to sustain and enhance quality and compliance performance on an ongoing basis, he added.

The USFDA in the warning letter issued to the company on November 5 last year had said it found several violations with regard to current good manufacturing practices (CGMP) in API manufacturing facilities at Srikakulam in Andhra Pradesh and Miryalaguda in Telangana, as well as in oncology formulation manufacturing facility at Duvvada, Visakhapatnam in AP.

In the warning letter the USFDA has said that DRL did not implement a robust quality system at its sites.

"Post receipt of the warning letter from USFDA in early November 2015 for three of our sites, we submitted on December 7, 2015 a Comprehensive Corrective and Preventive Action Plan, which in short is called 'CAPA' to address all the issues raised," Mukherjee said.

He further said: "We have submitted a status update to the warning letter response on January 28, 2016 stating our progress on accelerated remediation efforts towards sustainable compliance."

The company has also engaged third-party consultants, US-based Lachman consultants to provide necessary compliance and remediation support for assuring robust implementation and verification of the CAPA plan, he added.
Dr Reddy's Dr Reddy's Laboratories DRL pharma news pharma news india USFDA 
savita thakur thakur
savita thakur thakur
    Show Full Article
    Next Story
    Similar Posts
    NO DATA FOUND

    Editorial

    Safeguarding Mental Health of Doctors & How They Can Prevent a Burnout

    Safeguarding Mental Health of Doctors & How They Can Prevent a Burnout

    Analyzing the Role of Levofloxacin in Urinary Tract Infections-A review

    Analyzing the Role of Levofloxacin in Urinary Tract Infections-A review

    Management of Allergic Rhinitis during COVID-19 Pandemic

    Management of Allergic Rhinitis during COVID-19 Pandemic

    Role of Probiotics in recurrent bacterial vaginosis: A review

    Role of Probiotics in recurrent bacterial vaginosis: A review

    Decoding the correct diagnosis of Allergic Rhinitis in clinic practice - Dr Tushar Kanti Ghosh

    Decoding the correct diagnosis of Allergic Rhinitis in clinic practice - Dr Tushar Kanti Ghosh

    View All

    Journal Club Today

    Rivaroxaban effective in treating VTE in symptomatic peripheral artery disease after lower extremity

    Rivaroxaban effective in treating VTE in symptomatic peripheral artery disease after lower extremity

    View All

    Health News Today

    Health Bulletin 30/June/2022

    Health Bulletin 30/June/2022

    View All
    © 2022 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