shodhana logo
Carvedilol, Citalopram, Escitalopram

Achievements

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
  • ISO 9001-2008 AND 14000:2004 certification
  • EU written confirmation
  • Our facility has been approved by KFDA ( Korea)
  • Our facility has been approved by COFEPRIS (Mexico)
  • Our facility has been approved by TGA (Australia)

 

COS/CEP Status:

  • Carvedilol - COS/ CEP granted (CEP 2008 - 259)
  • Ondansetron Hydrochloride Dihydrate - COS / CEP granted (CEP 2009-114)
  • Citalopram Hydrobromide - COS/CEP granted (Rl-CEP 2010-228-Rev 00)
  • Duloxetine Hydrochloride - COS/CEP granted (RP-CEP 2013-340-Rev 00)
  • Rivastgmine - COS/CEP granted (RO-CEP 201S-236-Rev 00)

 

DMF Status

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, Carbidopa, Escitalopram Oxalate, Ondansetron Hydrochloride Dihydrate, Citalopram Hydrobromide. The company has also filed the DMF for Rivastigmine base in 31 European countries.

 

CSO WHO WHO

 

System And Audits:

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.

 

Quality

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.

 

Awards

INDIA'S SMALL GIANTS AWARD

INDIA SME 100 AWARD