Glenmark Pharmaceuticals has received a GMP certificate from SUKL (State Institute for Drug control), a regulator from the Czech Republic. The certificate is in regard to India-based Glenmark’s Baddi manufacturing unit.
The European regulator has issued a certificate of compliance for the global pharma company’s Indian facility stating that it complies with the principles and guidelines of Good Manufacturing Practice laid down in the directive 2003/94/EC which stipulates the requirements to fulfil GMP recommendations of WHO.
The Indian Baddi facility manufactures solid and liquid oral drugs, external preparations like lotions and creams and respiratory segment products.
"The Baddi facility is expected to contribute $30m in total sales for this financial year, which is approximately 7% of the total US sales," Glenmark said in a regulatory filing.
Glenmark is part of the branded generics markets across emerging economies including India. The company has 16 manufacturing facilities across five countries and has six R&D centers. The Generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.
