Regulatory Updates

• 16 November 2017, DMF of Isotretinoin API is submitted to Saudi Arabia Food and Drug Authority (SFDA)

 

• 30 September 2017, DMF of Isotretinoin API is listed on USFDA's Reference Available List

 

• 11 July 2017, DMF of Isotretinoin API is submitted to Kuwait MOH

 

• 30 June 2017, DMF of Isotretinoin Drug Substance is submitted to Korean KFDA

 

• 2 June 2017, DMF of Roflumilast API is submitted to Suadi Food and Drug Authority (SFDA)

 

• 22 February 2017, a renewed CEP for Acitretin drug substance is granted

 

• 8 February 2017, Calcipotriol (Calcipotriene) API is approved by Indian MOH (Form 41).

 

• 3 December 2016, a renewed CEP for Isotretinoin is available

 

• 24 August 2016, TDMF for Calcipotriol (Calcipotriene) is approved by Taiwan TFDA

 

• 10 May 2016, DMF of Bendamustine HCl monohydrate is listed in US-FDA’s Reference Available List

 

• 29 March 2016, Naftifine HCl is approved by Ukraine MOH

 

• 27 February 2016, DMF of Naftifine HCl is approved by Russian MOH

 

• 7 December 2015, CEP of Calcipotriol Monohydrate (Calcipotriene) is granted by EDQM

 

• 7 October 2015, DMF of Ruxolitinib Phosphate is listed in US-FDA’s Reference Available List

 

• 23 April 2015, DMF of Roflumilast is listed in US-FDA’s Reference Available List

 

• 27 January 2015, Acitretin Capsules passed the GMP inspection by Malaysia National Pharmaceutical Regulatory Agency (NPRA), which is a member of PIC/S

 

• 17 July 2014, application dossiers for Acitretin Capsules is submitted to Malaysia National Pharmaceutical Regulatory Agency (NPRA)

 

• 14 July 2014, GMP certificate for Isotretinoin API is granted by Mexico COFEPRIS

 

• 12 June 2014, GMP certificate for Isotretinoin API is granted by New Zealand MEDSAFE

 

• 3 April 2014, Calcipotriol Anhydrous (Calcipotriene) is approved by Greece MOH

 

• 27 September 2013, DMF of Bendamustine HCl API is listed in US-FDA’s Reference Available List

 

• 10 July 2012, GMP certificate for Isotretinoin API is granted by New Zealand MEDSAFE

 

• 13 November 2011, CEP of Isotretinoin drug substance is granted by EDQM