X
Pharma Advancement
  • Home
  • Articles
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    FDA Accepts BLA for Recommended

    FDA Accepts BLA for Recommended Biosimilar to Simponi

    Merck to Acquire Verona

    Merck to Acquire Verona Pharma in $10B Deal Boosts COPD Drug

    Emerging Oral Small Molecule Drugs

    Emerging Oral Small-Molecule Drugs for Ultra-Rare Diseases

    FDA Approves Oral Therapy for Treating Hereditary Angioedema

    FDA Approves Oral Therapy for Treating Hereditary Angioedema

    Avadel Pharmaceuticals Receives

    Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia

    Robots and AI in Drug

    Robots and AI in Drug Discovery Are Transforming Medicine

    Stringent Policy around COVID Vaccines Laid by FDA

    Stringent Policy around COVID Vaccines Laid by FDA

    Pharmaceutical-Chemicals Market Booms with Rising API Demand

    Pharmaceutical Chemicals Market Booms with Rising API Demand

    Next in Pharma 2025 Innovations

    Next in Pharma 2025: Innovations Shaping the Future

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Articles
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    FDA Accepts BLA for Recommended

    FDA Accepts BLA for Recommended Biosimilar to Simponi

    Merck to Acquire Verona

    Merck to Acquire Verona Pharma in $10B Deal Boosts COPD Drug

    Emerging Oral Small Molecule Drugs

    Emerging Oral Small-Molecule Drugs for Ultra-Rare Diseases

    FDA Approves Oral Therapy for Treating Hereditary Angioedema

    FDA Approves Oral Therapy for Treating Hereditary Angioedema

    Avadel Pharmaceuticals Receives

    Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia

    Robots and AI in Drug

    Robots and AI in Drug Discovery Are Transforming Medicine

    Stringent Policy around COVID Vaccines Laid by FDA

    Stringent Policy around COVID Vaccines Laid by FDA

    Pharmaceutical-Chemicals Market Booms with Rising API Demand

    Pharmaceutical Chemicals Market Booms with Rising API Demand

    Next in Pharma 2025 Innovations

    Next in Pharma 2025: Innovations Shaping the Future

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home News

Serum Institute gets DCGI nod to manufacture Sputnik V COVID-19 vaccine in India

Content Team by Content Team
7th June 2021
in News
Dr Reddy's Lab gets DCGI nod for Sputnik Phase 2 & 3 trials

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

The DCGI has granted permission to the Serum Institute of India (SII) to manufacture the Sputnik COVID-19 vaccine in India for examination, test and analysis with certain conditions.

The Pune-based firm has collaborated with Gamale.zya Research Institute of Epidemiology and Microbiology, Moscow in Russia for developing Sputnik V at its licensed Hadapsar facility. “The DCGI has granted permission to the Serum Institute to manufacture the Sputnik COVID-19 vaccine in India for examination, test and analysis at its licensed Hadapsar facility with certain conditions,” an official source said.

The company had submitted an application to the DCGI in this regard on Thursday. According to the four conditions set by the DCGI, the Serum Institute will have to submit a copy of the agreement between it and the Gamaleya Research Institute of Epidemiology and Microbiology for transfer of cell bank and virus stock and submit the copy of agreement for technology transfer with Gamaleya.

Further, the SII has to submit a copy of the RCGM permission to import cell bank and virus stock and a copy of the RCGM permission to initiate research and development of viral vector vaccine Sputnik V, the sources said.

The SII on May 18 had also applied to the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology seeking clearance for import of strains/seed lots and cell banks, and for carrying out research and development, the official sources said.

The RCGM has raised some queries over SII’s application and has sought a copy of material transfer agreement between the Pune-based firm and the Gamaleya Research Institute of Epidemiology and Microbiology. Russia’s Sputnik V vaccine is currently being manufactured by Dr Reddy’s Laboratories in India.

The SII plans to seek restricted emergency use permission of the vaccine in India.

Previous Post

Vetter Once Again Wins Axia Best Managed Companies Award

Next Post

Greenphire Announces Strategic Growth Investment from Thoma Bravo

Related Posts

FDA Accepts BLA for Recommended
FDA Approvals

FDA Accepts BLA for Recommended Biosimilar to Simponi

22nd July 2025
Merck to Acquire Verona
Drug Development

Merck to Acquire Verona Pharma in $10B Deal Boosts COPD Drug

21st July 2025
ChiRhoClin LogiCare3PL Partners for Drug Distribution
News

ChiRhoClin, LogiCare3PL Partners for Drug Distribution

21st July 2025
Thermo Fisher and Sanofi Partners
Manufacturing

Thermo Fisher and Sanofi Partners for US Drug Manufacturing

21st July 2025
EMA Recommendations to Secure Anti D Immunoglobulins Supply
News

EMA Recommendations to Secure Anti-D Immunoglobulins Supply

15th July 2025
FDA Approves Oral Therapy for Treating Hereditary Angioedema
FDA Approvals

FDA Approves Oral Therapy for Treating Hereditary Angioedema

15th July 2025
Next Post
Greenphire Announces Strategic Growth Investment from Thoma Bravo

Greenphire Announces Strategic Growth Investment from Thoma Bravo

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Subscribe Us

System

  • Search
  • Sitemap
  • RSS Feed

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack
  • Newsletters Archive

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Articles
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

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

Log In