Since its establishment, Shodhana has achieved several milestones as the manufacturer of bulk actives, pharma chemicals and ingredients for pharmaceutical applications. Some of the achievements are:
WHO GMP certification
Our facility has been inspected by USFDA
Our facility has been approved by KFDA ( Korea)
ISO 9001-2008 AND 14000:2004 certification
Our facility has been approved by TGA (Australia)
EU written confirmation
Our facility has been approved by COFEPRIS (Mexico)
Accreditation of Foreign Manufacturer by PMDA Japan
The company has filed EDMFs for Carvedilol, Escitalopram Oxalate, Ondansetron Hydrochloride Dihydrate, Rivastigmine Hydrogen Tartrate, Citalopram Hydrobromide, an UK DMF for Citalopram Hydrobromide, US DMF for Duloxetine Hydrochloride and TDMFs ( Taiwan) for Carvedilol , Duloxetine Hydrochloride, Escitalopram Oxalate, Ondansetron Hydrochloride Dihydrate, Citalopram Hydrobromide. The company has also filed the DMF for Rivastigmine base in 31 European countries.
Shodhana is an ISO 9001-2008 certified company and also a WHO GMP certified company holding the status for the past seven years. The company has all the cGMP systems in place with a well established quality assurance department which monitors, guides, audits, checks and controls all the GMP activities. The company has been successfully audited by many international customers besides large domestic and MNC customers for its adherence to cGMP and quality systems.
Shodhana is committed towards furnishing superior quality products. For that a team of pharmaceutical quality control experts minutely scan each and every stage of production. Shodhana has integrated quality control lab which is well-equipped with modern analytical equipments in place that include HPLCs , GCs (Head space and normal), HPLC systems, UV/VIS/FTIR spectrophotometers, Digital polarimeter and auto titrates etc. besides the conventional analytical equipments. These machines are used to carry out impurity profiles and regular analysis of products.