Indoco Remedies has received Certificate of Good Manufacturing Practice (GMP) Compliance for its Goa Plant II which is located at Verna Industrial Estate, Goa from the State Institute for Drug Control (SUKL), Czech Republic. The certificate pertains to manufacture of sterile ophthalmic formulations.
The plant has been inspected in connection with marketing authorization(s) listing manufacturer, located outside of the European Economic Area in accordance with Art. 111(4) of the Directive 2001/83/EC transposed in the hollowing national legislation: Section 101 paragraph 3 of Act No. 378/2007 COIL., on Pharmaceuticals and on Amendment to Some Reined Acts (the Act of Pharmaceuticals) as amended. From the knowledge gained during inspection of Plant II, the latest which was conducted on 09/11/2013 it is considered that it complies with the principles and guidelines of Good manufacturing Practice laid down in Directive 2003/94/EC.
Directive 2001/83/EC of the European Parliament and of the council of November 6, 2001 relates to control of medicinal products for human use in the EU.
The GMP certificate confirms that the plant fulfills the GMP recommendations of World Health Organisation (WHO).