On January 19, 2016, Gland Chemicals Private Limited (Gland) secured Written Certifications of Exports to the European Union from the Central Drugs Standard Control Organization (CDSCO) for three (3) of its active pharmaceutical ingredients (APIs), including:
For years, low-priced raw material from China helped build India's generic drug industry into a global powerhouse. Now, that advantage is turning out to be the biggest weakness - if not a full-scale threat - for the country's bulk drug manufacturers.
Agency suspends pharmaceutical ingredients Parabolic Drugs Limited company
FDA actions taken against Indian drugmakers have grabbed a lot of attention in recent years, but Europe has also been pushing foreign suppliers to hit higher standards. Each country does its own inspections but then shares any issues it finds through a common website. Most recently, Italy flagged problems with three plants, two in China and one in India.