research
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India,
2016-07-22 12:15
(2834 d 10:25 ago)

(edited by Dr_Dan on 2016-08-03 17:38)
Posting: # 16512
Views: 4,246
 

 regulatory status in India [Regulatives / Guidelines]

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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
(2824 d 08:36 ago)

(edited by Dr_Dan on 2016-08-03 17:32)
@ research
Posting: # 16533
Views: 3,335
 

 regulatory status in India

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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
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India,
2016-08-01 14:29
(2824 d 08:11 ago)

(edited by Dr_Dan on 2016-08-03 17:31)
@ pravin17
Posting: # 16534
Views: 3,270
 

 regulatory status in India

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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
(2816 d 06:38 ago)

@ research
Posting: # 16547
Views: 3,033
 

 regulatory status in India

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You need to apply under category 1 of NOC check list
 
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