INDIA – IOL Chemicals and Pharmaceuticals Limited (IOL) has received a Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines and Healthcare (EDQM) to supply Paracetamol across the European market.
It is projected to further cement IOL Chemicals and Pharmaceuticals Limited’s position as one of the top pharma Active Pharmaceutical Ingredients (API) and speciality chemicals manufacturers in the world.
With this CEP certification, IOL will export thousands of batches of Paracetamol to the entire European region while ensuring a continuous supply of this pain medication.
IOL Chemicals and Pharmaceuticals Limited earns the latest accreditation based on the organization’s compliance with pharmaceutical substances standards set by the European regulator.
Similarly, the Indian manufacturer received EDQM’s certification to supply Pantoprazole Sodium Sesquihydrate API across the European market.
Europe is India’s biggest buyer of paracetamol APIs and imports around 12,000 tonnes annually.
The EDQM certification reinforces India’s position as the world’s main supplier of generic drugs and reaffirms that the Indian API supplier meets the highest global standards.
Furthermore, IOL has received the go-ahead to export Paracetamol to the European continent as the company bolsters its manufacturing capabilities to produce this pharmaceutical drug.
In 2022, the company began commercial production of Paracetamol at its manufacturing facility in Punjab located in the Northwestern part of the Indian subcontinent.
IOL’s Punjab-based facility is also backward integrated to produce the key starting material for Paracetamol.
Currently, IOL has a total capacity of 3,600 tonnes to produce Paracetamol, which is sold as acetaminophen in all European countries with or without prescription.
With EDQM backing, the Indian-based company will significantly expand its manufacturing capacity at its production facilities situated at its unit in Punjab.
IOL is the world’s largest producer of Ibuprofen API with a 33 percent market share globally.
The company supplies its pharmaceuticals to the UK, Belgium, Hungry, Spain, Germany, Italy, Netherlands, Switzerland, Poland, Ireland, the US, Peru, Brazil, Argentina, Colombia, Indonesia, South Korea, Thailand, Bangladesh, Turkey, the UAE, China, Hong Kong, and Egypt.
Additionally, the company has over 13 APIs in its portfolio, including Metformin, Fenofibrate, Lamotrigine, Clopidogrel Bisulphate, and Pantoprazole.
The recent certification by EDQM will promote pharmaceutical traceability to help in stemming the rising number of complications of managing an overdose of products containing paracetamol in Europe.
It comes as the National Agency for the Safety of Medicines (ANSM) called for pharmacists in France to ration the sale of paracetamol.
In the same steps, the Chinese government banned exports of paracetamol despite the country’s wide-scale production of the active ingredient.
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