research
☆    

India,
2016-07-22 12:15
(2827 d 20:42 ago)

(edited by Dr_Dan on 2016-08-03 17:38)
Posting: # 16512
Views: 4,217
 

 regulatory status in India [Regulatives / Guidelines]

How do we know FDC (Amlodipine 2.5mg + Atorvastatin 20mg) is avilable in Indian market as on CDSCO webiste different strenght is available.


Edit: Post unto others as you would have others post unto you. It’s nice to start your post with a salutation, and include a signature as well. Dr_Dan

Please see the Forum’s Policy.
pravin17
★    

India,
2016-08-01 14:04
(2817 d 18:52 ago)

(edited by Dr_Dan on 2016-08-03 17:32)
@ research
Posting: # 16533
Views: 3,311
 

 regulatory status in India

Only  FDC of Amlodipine (5mg/10 mg) + Atorvastatin (10/20/40 mg)is approved in INDIA.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Dr_Dan]
research
☆    

India,
2016-08-01 14:29
(2817 d 18:27 ago)

(edited by Dr_Dan on 2016-08-03 17:31)
@ pravin17
Posting: # 16534
Views: 3,246
 

 regulatory status in India

Thank you for your prompt reply.
Wondering can not get BE NOC for (Amlodipine 2.5mg + Atorvastatin 20mg) as per modified release drug.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Dr_Dan]
pravin17
★    

India,
2016-08-09 16:02
(2809 d 16:54 ago)

@ research
Posting: # 16547
Views: 3,010
 

 regulatory status in India

You need to apply under category 1 of NOC check list
UA Flag
Activity
 Admin contact
22,987 posts in 4,824 threads, 1,663 registered users;
76 visitors (0 registered, 76 guests [including 3 identified bots]).
Forum time: 08:57 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5