Aspen API. More than just an API.
01 1Aspen API
02 1LGM Pharma
03 1Fermion Oy
04 1Fine Chemicals Corporation PTY Ltd
05 1DKSH
06 1Aarti Pharmalabs
07 1Granules India Limited
08 1Biotechnica DWC
09 1Globofarm International
10 1Guangzhou Tosun Pharmaceutical
11 1MSN Laboratories
12 1Medigraph Pharmaceuticals Pvt. Ltd.
13 1Micro Orgo Chem
14 1Microbiologica
15 1Promethera Biosciences
16 2RPG Life Sciences
17 2Raks Pharma
18 1Rakshit Drugs
19 3Resolution Chemicals Limited
20 1Sneha Medicare Pvt Ltd
21 1Tecoland Corporation
22 1Viatris
23 3Zhejiang Cheng Yi Pharmaceutical Co., Ltd
24 1Zydus Lifesciences
01 1Algeria
02 1Brazil
03 4China
04 1Finland
05 13India
06 1Netherlands
07 1South Africa
08 1Switzerland
09 4U.S.A
10 3United Kingdom
01 11Active
02 6Inactive
03 13Blank
01 1Expired
02 8Valid
03 1Withdrawn by Holder
04 20Blank
01 1219MF10383
02 29Blank
01 1WC-0024
02 1WC-0056
03 1WC-0099
04 27Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34647
Submission : 2020-09-18
Status : Active
Type : II
Certificate Number : R1-CEP 2017-171 - Rev 00
Issue Date : 2023-02-13
Type : Chemical
Substance Number : 369
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-09-14
Pay. Date : 2016-08-29
DMF Number : 5408
Submission : 1984-03-19
Status : Active
Type : II
Certificate Number : CEP 2006-317 - Rev 02
Issue Date : 2024-08-23
Type : Chemical
Substance Number : 369
Status : Valid
Registration Number : 219MF10383
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2007-12-19
Latest Date of Registration : --
NDC Package Code : 12780-0300
Start Marketing Date : 1997-06-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2022-05-09
Registration Number : 20220509-209-J-1288
Manufacturer Name : Fermion Oy, Hangon tehdas
Manufacturer Address : Orioninkatu 2, Hanko, FI-10900, Finland
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10119
Submission : 1993-02-19
Status : Active
Type : II
NDC Package Code : 48954-909
Start Marketing Date : 1993-02-19
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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23038
Submission : 2009-08-11
Status : Active
Type : II
Certificate Number : R1-CEP 2014-030 - Rev 01
Issue Date : 2022-10-20
Type : Chemical
Substance Number : 369
Status : Valid
Date of Issue : 2023-01-06
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm :
NDC Package Code : 15308-0732
Start Marketing Date : 2004-02-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2021-11-15
Registration Number : 20211115-209-J-1152
Manufacturer Name : Aarti Pharmalabs limited
Manufacturer Address : Plot No: E–50, 50/1 & 59/1, MIDC, Tarapur, Taluka & District: Palghar, Pin-401 506, Maharashtra, India.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-11-30
Pay. Date : 2018-08-07
DMF Number : 33056
Submission : 2018-08-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23179
Submission : 2009-10-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21674
Submission : 2008-06-04
Status : Inactive
Type : II
Certificate Number : CEP 2001-341 - Rev 10
Issue Date : 2024-04-12
Type : Chemical
Substance Number : 369
Status : Valid
Date of Issue : 2022-06-03
Valid Till : 2025-07-28
Written Confirmation Number : WC-0056
Address of the Firm :
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