01 1AbbVie Inc
02 1Neuland Laboratories
03 1TAPI Technology & API Services
04 1ALP Pharm
05 2Catalent Pharma Solutions
06 1Chongqing Huapont Pharmaceutical
07 1DISHMAN NETHERLANDS B.V.
08 1Formosa Laboratories
09 1Nanjing Heron Pharmaceutical
10 1Sai Life Sciences Limited
01 4PARICALCITOL
02 1PARICALCITOL DRUG SUBSTANCE
03 2PARICALCITOL USP
04 1PARICALCITOL USP (NON-STERILE DRUG SUBSTANCE)
05 1PARICALCITOL USP, NON-STERILE BULK DRUG
06 1ZEMPLAR (PARACALCITOL) CAPSULES, 1 MCG
07 1ZEMPLAR (PARICALCITOL) 2 & 4 MCG CAPSULES
01 3China
02 2India
03 1Israel
04 1Netherlands
05 1Taiwan
06 3U.S.A
01 9Active
02 2Inactive
01 3Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24315
Submission : 2010-11-30
Status : Active
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23895
Submission : 2010-06-18
Status : Active
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 20865
Submission : 2007-09-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21255
Submission : 2008-01-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16402
Submission : 2003-02-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28550
Submission : 2014-07-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25300
Submission : 2011-09-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-11-23
DMF Number : 21880
Submission : 2008-08-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38269
Submission : 2023-08-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-09
Pay. Date : 2012-11-21
DMF Number : 26545
Submission : 2012-11-14
Status : Active
Type : II
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