Bioequivalence and Bioavailability Forum • Calcitriol 0.5 mcg tablet

Calcitriol 0.5 mcg tablet [Regulatives / Guidelines]

posted by drgunasakaran1 – 2012-02-29 10:41 (5233 d 04:51 ago) – Posting: # 8186
Views: 5,157

Dear Mr.Vicky,

Calcitriol soft gelatin capsules was approved by CDSCO on Aug, 1993.

Calcitriol was available only as 0.25 mcg strength in the Indian Market.

I hope you are inquiring about Calcitriol 0.5 mcg tablet, not 0.5 mg tablet. Considering Calcitriol tablet 0.5 mcg as strength, you need to get BE NOC approval from DCGI before conducting BE study since the strength and the formulation is not approved by CDSCO for marketing in India.

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

Complete thread:

Calcitriol 0.5mg tablet vicky 2012-02-29 08:45
- Calcitriol 0.5 mcg tabletdrgunasakaran1 2012-02-29 09:41
  - Calcitriol 0.5 mcg tablet vicky 2012-02-29 09:47
    - Calcitriol 0.5 mcg tablet drgunasakaran1 2012-02-29 10:18
      - Calcitriol 0.5 mcg tablet vicky 2012-03-01 07:54
        
        Calcitriol 0.5 mcg tablet drgunasakaran1 2012-03-01 14:59