research
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India,
2016-07-22 12:15
(3271 d 03:54 ago)

(edited on 2016-08-03 17:38)
Posting: # 16512
Views: 5,028
 

 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
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India,
2016-08-01 14:04
(3261 d 02:04 ago)

(edited on 2016-08-03 17:32)
@ research
Posting: # 16533
Views: 3,896
 

 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
(3261 d 01:39 ago)

(edited on 2016-08-03 17:31)
@ pravin17
Posting: # 16534
Views: 3,853
 

 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
(3253 d 00:07 ago)

@ research
Posting: # 16547
Views: 3,627
 

 regulatory status in India

You need to apply under category 1 of NOC check list
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