Regulatory Agency
| Authority | Name of Regulatory Agency | Nos. |
|---|---|---|
|
USA |
No: of Sites(Bulk drugs + Formulations) Registered with US FDA (as on 15th april20l 5)
|
238
|
|
|
No: of Sites(Bulk drugs + Formulations) Registered with US FDA (as on 15th april20l 5)
|
605
|
|
|
Total No Of DMFs (Type II Active) filed from India (as on 31 St Dec 2019
|
3820 |
|
|
ANDAs(Ason Feb2016)
|
3470
|
|
EUROPE |
Formulation companies withUSFDA approvals.
|
53 |
|
|
Number of CEPs received (as of February 2016)
|
1354 |
|
|
Number of companies with CEPs
|
220 |
|
|
Number of Molecules for which CEPs have been filed with EDQM
|
382 |
|
|
No of Sites with EU GMP Compliance as on 1 5thFebruary 2016
|
631 |
|
|
UK MHRA (Medicines Healthcare Regulatory Agency), Market authorizations as on March 2015
|
1559 |
|
|
Number of CEPs with Irish Medicines Board
|
300 |
|
|
Number of companies registered in Irish Medicines Board
|
19 |
|
|
Number of Authorisations with Sweden MPA (Lakemedelsverket)
|
209 |
|
|
Number of companies having MA s with Sweden MPA (Lafcemedelsverket)
|
14 |
|
WHOGMP
|
WHO GMP Certified Plants (as per Drug Controller General of India)
|
1400 |
|
Ethiopia |
DACA (Drug Administration and Control Authority), Ethiopia (companies)
|
50 |
|
Tanzania
|
(TFDA) Tanzania Food and Drugs Authority (companies)
|
1373 |
