Last Updated on January 24, 2024 by The Health Master
Saudi’s GMP certification to Venus
Venus Remedies, one of the world’s top 10 fixed-dosage injectable manufacturers, has received the Good Manufacturing Practices (GMP) certification from Saudi Arabia for all its production facilities at its unit in Baddi, Himachal Pradesh.
This certification is expected to pave the way for marketing authorizations from other countries in the GCC and MENA regions, as the Saudi Food and Drug Authority (SFDA) is considered a reference authority in these regions.
Certification Details
The SFDA granted the GMP certification, after an extensive review and audit of the company’s facilities, which included:
First-time approval for:
- Pre-filled Enoxaparin syringes,
- General injection facilities.
Renewed approval for:
- Cephalosporin antibiotic
- Carbapenem antibiotic
- Liquid and lyophilised oncology drugs.
Venus Remedies has a fully automated robotic PFS (Prefilled Syringe) machine that ensures optimum quality.
Products Covered by GMP Certification
The GMP certification for three more facilities applies to small-volume injectables, dry-powder vials, liquid vials and ampoules, and lyophilised vials.
Venus Remedies is planning to consolidate its position in Saudi Arabia and other GCC countries through product registrations and common technical dossiers (CTDs).
Marketing Authorizations
Venus Remedies has already filed a CTD in Saudi Arabia for Enoxaparin, for which marketing approval is expected shortly.
The company is also awaiting marketing authorization from Saudi Arabia for another six-seven oncology products anytime soon.
Since 2014, Venus Remedies has sold more than 12 million units of drugs in the $7.8-billion Saudi Arabian pharmaceutical market (as of 2021), which is expected to grow to $13.1 billion by 2031 at a 10-year CAGR of 5.4 per cent.
Conclusion
The GMP certification from Saudi Arabia is a significant milestone for Venus Remedies, as it will not only help the company consolidate its position in the Saudi Arabian market, but also pave the way for marketing authorizations from other countries in the GCC and MENA regions.
With its commitment to quality and innovation, Venus Remedies is poised to make a significant contribution to the global pharmaceutical industry.
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