Regulatory Updates

2020

· April 2020, TDMF for Moxifloxacin HCl is approved by Taiwan FDA

· April 2020, US-DMF of Bendamustine HCl was approved by FDA (allied dosage was approved).

· February 2020, Moxifloxacin HCl obtained the GMP certificate issued by PMDA (Japan FDA).

· January 2020, Roflumilast, Calcipotriol Monohydrate, Alitretinoin and other five APIs obtained W/C (Written Confirmation).

2019

· July 2019, Tretinoin, Tazarotene, Acrivastine and other four APIs obtained W/C (Written Confirmation).

· April 2019, Isotretinoin and Acitretin obtained renewal W/C (Written Confirmation).

· February 2019, Moxifloxacin Hydrochloride, Olopatadine Hydrochloride and Linezolid obtained the GMP certificate issued by China-NMPA (National Medical Products Administration)

· January 2019, Alitretinoin obtained the GMP certificate from South Korean FDA

· January 2019, Isotretinoin process 2 obtained CEP certification (2018-219)

2018

· 20 September 2018, the manufacturing site is informed approve the US-FDA inspection.

· 16-18 July 2018, the manufacturing site is accepted the inspection of US-FDA

2017

· 16 November 2017, DMF of Isotretinoin is submitted to Suadi FDA

· 30 September 2017, US-DMF of Isotretinoin is listed in FDA’s reference available list.

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

· 30 June 2017, DMF of Isotretinoin is submitted to Korean FDA

· 2 June 2017, DMF of Roflumilast is submitted to Suadi FDA

· 22 February 2017, a Renewed CEP for Acitretin is available

· 8 February 2017, Form 41 is obtained issued by Indian MOH

2016

· 3 December 2016, a Renewed CEP for Isotretinoin is available

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

· 24 August 2016, TDMF for Calcipotriol (Calcipotriene) is approved by Taiwan FDA

2014

· 3 April 2014, Calcipotriol (Calcipotriene) anhydrous is approved by Greece MOH

2011

· 13 November 2011, CEP of Isotretinoin is issued by EDQM