Venus Remedies gets Ukrainian GMP approval for carbapenem, oncology parenteral facilities
The company is looking to expands its product portfolio in other EU markets as well
Venus Remedies has received Good Manufacturing Practices (GMP) certification from Ukraine for Meropenem 500 mg, Meropenein 1000 mg, Meropenem 2000 mg, Oxaliplatin 5mg/ml, Paclitaxil 6 mg/ml, Cisplatin l mg/ml, Imipenem/Cilastatin 500 mg/500 mg of its carbapenem and oncology production facilities at its unit in Baddi, Himachal Pradesh.
Granted by the State Service of Ukraine on Medicine and Dug Control (SMDC), this certification is expected to pave the way for GMP certifications for Venus Remedies from European Medicines Agency and many medicines regulatory authorities of European Union (EU) member states and other countries spread across the globe which follow the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S).
This international GMP approval, the 27th for Venus Remedies, will also enable the company to expand its product portfolio globally with more marketing authorisations not only from Ukraine, but other global markets as well.
PIC/S includes 54 countries, which together represent a $222 billion market, and Venus Remedies is present in 04 PIC/S member states. The company also has a presence in 16 countries in the EU, which has a market size of $350 billion.
The approval covers the company’s non-cephalosporin (calbapenem) and oncology parenteral facilities, comprising liquid and lyophilised injections, ampoules, liquid vials, general lyophilised vials, prefilled syringes and intravenous fluids.