Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Coral Drugs Private Limited
03 1Vamsi Labs
04 1Axplora
05 1LGM Pharma
06 1Fermion Oy
07 1Jai Radhe Sales
08 1Aarti Pharmalabs
09 1Gangwal Healthcare
10 1HRV Global Life Sciences
11 1Amphastar Pharmaceuticals
12 1Aspire Lifesciences Pvt Ltd
13 1Astellas Pharma
14 1Beijing Breathgreen Healthcare
15 1CHEMO
16 1Cipla
17 1DEAFARMA
18 1Guangzhou Tosun Pharmaceutical
19 1Harman Finochem
20 1Hasti Aria Shimi
21 2Industriale Chimica
22 1Jayco Chemical Industries
23 2Lusochimica
24 2MSN Laboratories
25 1Melody Healthcare Pvt Ltd
26 1ST Pharma
27 1Sicor Societa Italiana Corticosteroidi Srl
28 1Teva API
29 1Teva Pharmaceutical Industries
30 1Viatris
31 1Zhejiang Tiantai Pharmaceutical
32 1Blank
01 3China
02 1Finland
03 1Germany
04 13India
05 1Iran
06 2Israel
07 6Italy
08 1Japan
09 1South Korea
10 2Spain
11 3U.S.A
12 1Blank
01 11Active
02 4Inactive
03 20Blank
01 12Valid
02 2Withdrawn by Holder
03 21Blank
01 1224MF10042
02 1227MF10062
03 1229MF10130
04 1229MF10159
05 31Blank
01 1WC-0009
02 1WC-0021
03 1WC-0021n
04 1WC-0099
05 1WC-0144
06 1WC-0155
07 1WC-0157
08 1WC-0227
09 27Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-16
Pay. Date : 2017-05-10
DMF Number : 16628
Submission : 2003-06-03
Status : Active
Type : II
Certificate Number : R1-CEP 2006-024 - Rev 02
Issue Date : 2020-10-15
Type : Chemical
Substance Number : 1724
Status : Valid
Registration Number : 224MF10042
Registrant's Address : Area Industrial del Llobregat, C/Argent 1,08755 Castellbisbal Barcelona SPAIN
Initial Date of Registration : 2012-02-28
Latest Date of Registration : --
NDC Package Code : 64567-0006
Start Marketing Date : 2008-06-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2013-08-19
Registration Number : 20130819-187-I-288-06
Manufacturer Name : INKE SA
Manufacturer Address : Argent,1, Area Industrial del Llobregat, Castellbisbal 08755 (Barcelona), Spain.
Available Reg Filing : CN |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30324
Submission : 2016-06-04
Status : Active
Type : II
Certificate Number : R1-CEP 2016-105 - Rev 00
Issue Date : 2022-09-28
Type : Chemical
Substance Number : 1724
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-07-05
Written Confirmation Number : WC-0009
Address of the Firm :
NDC Package Code : 49076-7001
Start Marketing Date : 2016-02-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Certificate Number : R1-CEP 2006-227 - Rev 02
Issue Date : 2022-07-28
Type : Chemical
Substance Number : 1724
Status : Valid
Date of Issue : 2022-06-13
Valid Till : 2025-07-02
Written Confirmation Number : WC-0155
Address of the Firm :
NDC Package Code : 66412-0204
Start Marketing Date : 2023-09-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32936
Submission : 2018-07-27
Status : Active
Type : II
Certificate Number : R1-CEP 2010-132 - Rev 01
Issue Date : 2017-08-11
Type : Chemical
Substance Number : 1724
Status : Valid
NDC Package Code : 46439-8763
Start Marketing Date : 2018-06-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-19
Pay. Date : 2019-06-25
DMF Number : 33894
Submission : 2019-07-12
Status : Active
Type : II
Certificate Number : CEP 2015-215 - Rev 02
Issue Date : 2023-09-04
Type : Chemical
Substance Number : 1724
Status : Valid
Registration Number : 229MF10159
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2017-08-17
Latest Date of Registration : --
NDC Package Code : 12780-4880
Start Marketing Date : 2016-01-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Certificate Number : R1-CEP 2013-220 - Rev 02
Issue Date : 2022-10-20
Type : Chemical
Substance Number : 1724
Status : Valid
Date of Issue : 2023-01-06
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm :
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2018-10-24
Registration Number : 20160310-187-I-468-08(2)
Manufacturer Name : Aarti Industries Limited
Manufacturer Address : Unit-IV, Plot No. E-50, MIDC, Tarapur, TAL, Palghar, Dist Thane 401506, Maharashtra State, India
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