Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
01 1Deccan Nutraceuticals Pvt. Ltd
02 1LGM Pharma
03 1HRV Global Life Sciences
04 1Nortec Quimica
05 3Alembic Pharmaceuticals Limited
06 2Amino Chemicals
07 1Apotex Pharmachem
08 1Aspire Lifesciences Pvt Ltd
09 1Aurobindo Pharma Limited
10 2Boehringer Ingelheim GmbH
11 1CHEMO
12 1Chr. Olesen Synthesis A.S
13 1Cipla
14 1Curia
15 1Enaltec Labs Private Limited
16 1Erregierre SpA
17 1Guangzhou Tosun Pharmaceutical
18 1Hetero Drugs
19 2MSN Laboratories
20 1Macleods Pharmaceuticals Limited
21 1Nosch Labs Pvt
22 1Olon S.p.A
23 1Orchid Pharma
24 1Par Pharmaceutical
25 1Perrigo API India Private Limited
26 1Piramal Pharma Solutions
27 1SNA Healthcare
28 1Shouyuan Chemical
29 1Sun Pharmaceutical Industries Limited
30 1Synthon Pharmaceuticals
31 1Tianish Laboratories
32 1Torrent Pharmaceuticals Limited
33 1Unichem Laboratories Limited
34 1Varion Lifesciences
35 1Viatris
36 1Wockhardt
37 1Yangtze River Pharmaceutical Group
38 1Yonsung Fine Chemicals
39 1Zhuhai Rundu Pharmaceutical
40 1Zydus Lifesciences
01 1Brazil
02 1Canada
03 4China
04 1Denmark
05 2Germany
06 24India
07 2Italy
08 2Malta
09 1Netherlands
10 1South Korea
11 1Spain
12 5U.S.A
01 22Active
02 2Inactive
03 21Blank
01 16Valid
02 2Withdrawn by Holder
03 27Blank
01 1223MF10156
02 1223MF10181
03 43Blank
01 1WC-0017
02 1WC-0021
03 1WC-0021n
04 1WC-0027
05 1WC-0040
06 1WC-0063
07 1WC-0079
08 1WC-0081
09 1WC-0081A3
10 1WC-0082
11 1WC-0084
12 1WC-0123
13 1WC-0128
14 1WC-0144nA2
15 1WC-0157
16 1WC-0168
17 1WC-0197
18 28Blank
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21631
Submission : 2008-05-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22869
Submission : 2009-06-12
Status : Active
Type : II
Certificate Number : R1-CEP 2010-174 - Rev 01
Issue Date : 2020-04-09
Type : Chemical
Substance Number : 2416
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24781
Submission : 2011-06-23
Status : Active
Type : II
Certificate Number : R0-CEP 2012-149 - Rev 00
Issue Date : 2014-07-15
Type : Chemical
Substance Number : 2416
Status : Withdrawn by Holder
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-07
Pay. Date : 2013-07-24
DMF Number : 25907
Submission : 2012-03-30
Status : Active
Type : II
Certificate Number : CEP 2012-193 - Rev 01
Issue Date : 2024-11-12
Type : Chemical
Substance Number : 2416
Status : Valid
Date of Issue : 2022-06-30
Valid Till : 2025-07-28
Written Confirmation Number : WC-0063
Address of the Firm :
NDC Package Code : 53747-038
Start Marketing Date : 2012-03-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21899
Submission : 2008-10-25
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-28
Pay. Date : 2016-04-27
DMF Number : 30186
Submission : 2016-03-07
Status : Active
Type : II
Certificate Number : R1-CEP 2014-313 - Rev 01
Issue Date : 2022-01-07
Type : Chemical
Substance Number : 2416
Status : Valid
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0123
Address of the Firm :
NDC Package Code : 65085-0056
Start Marketing Date : 2016-05-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
A Pramipexole Dihydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pramipexole Dihydrochloride, including repackagers and relabelers. The FDA regulates Pramipexole Dihydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pramipexole Dihydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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