Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ChemWerth Inc
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1Apothecon Pharmaceuticals
05 1Aspire Lifesciences Pvt Ltd
06 1Aurobindo Pharma Limited
07 1Emcure Pharmaceuticals
08 1Hetero Drugs
09 1Hubei Honch Pharmaceutical
10 1NerPharMa
11 1Olon S.p.A
12 1Shilpa Medicare
13 1Sichuan Huiyu Pharmaceutical
14 1Sionc Pharmaceuticals
15 1Vannsh Life Sciences
16 1Xian Libang Pharmaceutical Co.,Ltd
01 3China
02 1Germany
03 9India
04 2Italy
05 1U.S.A
01 10Active
02 1Inactive
03 5Blank
01 16Blank
01 16Blank
01 1WC-0041
02 1WC-0147A3
03 1WC-0226
04 1WC-0273
05 1WC-0369
06 11Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-21
Pay. Date : 2013-09-05
DMF Number : 25791
Submission : 2012-02-14
Status : Active
Type : II
NDC Package Code : 46439-8735
Start Marketing Date : 2011-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg Filing : EU, CN, SAU |
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-21
Pay. Date : 2012-11-21
DMF Number : 25644
Submission : 2011-12-29
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-24
Pay. Date : 2013-09-25
DMF Number : 27485
Submission : 2013-09-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-01
Pay. Date : 2015-05-22
DMF Number : 20883
Submission : 2007-09-24
Status : Active
Type : II
NDC Package Code : 17337-0304
Start Marketing Date : 2010-04-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-08
Pay. Date : 2016-09-21
DMF Number : 29537
Submission : 2015-07-09
Status : Active
Type : II
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0087
Start Marketing Date : 1992-11-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-06-15
Pay. Date : 2022-06-03
DMF Number : 37179
Submission : 2022-06-04
Status : Active
Type : II
NDC Package Code : 59651-684
Start Marketing Date : 2023-12-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-18
Pay. Date : 2014-07-23
DMF Number : 27306
Submission : 2013-07-10
Status : Active
Type : II
Registrant Name : Saizen Korea Co., Ltd.
Registration Date : 2024-04-16
Registration Number : 20240416-210-J-1636
Manufacturer Name : NerPharMa Srl
Manufacturer Address : Viale Pasteur, 10, 20014 NERVIANO (MILANO), Italy
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-04-23
Pay. Date : 2014-12-31
DMF Number : 28930
Submission : 2015-01-03
Status : Active
Type : II
Date of Issue : 2021-06-11
Valid Till : 2022-07-02
Written Confirmation Number : WC-0147A3
Address of the Firm :
NDC Package Code : 82920-020
Start Marketing Date : 2022-08-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-07
Pay. Date : 2013-12-13
DMF Number : 25040
Submission : 2011-07-01
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
NDC Package Code : 14593-847
Start Marketing Date : 2023-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Pharma Co., Ltd.
Registration Date : 2019-11-07
Registration Number : 20191107-210-J-469
Manufacturer Name : Emcure Pharmaceuticals Limited
Manufacturer Address : Plot No. D-24 & D-24/1, MIDC, Kurkumbh, Taluka- Daund, Pune, 413 802, Maharashtra, India.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23667
Submission : 2010-04-01
Status : Inactive
Type : II
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