Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ChemWerth Inc
03 1LGM Pharma
04 1Fareva
05 1Apicore LLC
06 1Archimica
07 1ChemPacific Corp
08 1DMFs Not Supported
09 2Emcure Pharmaceuticals
10 1Fresenius Kabi AB Brunna
11 1Fresenius Kabi Oncology Limited
12 1Hetero Drugs
13 1Kekule Pharma
14 2Natco Pharma
15 1Sakar Healthcare
16 1Shilpa Medicare
17 1Shivalik Rasayan
18 1Vannsh Life Sciences
19 1Viatris
01 1Germany
02 12India
03 1Italy
04 1Luxembourg
05 1Sweden
06 4U.S.A
07 1Blank
01 7Active
02 3Inactive
03 11Blank
01 7Valid
02 14Blank
01 1230MF10027
02 20Blank
01 1WC-0041
02 1WC-0115
03 1WC-0147
04 1WC-0226
05 1WC-0372
06 1WC-0372(1)
07 15Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-08
Pay. Date : 2012-12-17
DMF Number : 25933
Submission : 2012-03-27
Status : Active
Type : II
Certificate Number : R0-CEP 2018-265 - Rev 00
Issue Date : 2020-03-24
Type : Chemical
Substance Number : 542
Status : Valid
NDC Package Code : 46439-8734
Start Marketing Date : 2011-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharma Science Korea Co., Ltd.
Registration Date : 2022-06-08
Registration Number : 20220608-210-J-1307
Manufacturer Name : Farmabios SpA
Manufacturer Address : Via Pavia 1, Gropello Cairoli, 27027, Italy
Available Reg Filing : SAU |
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-03
Pay. Date : 2014-07-10
DMF Number : 27006
Submission : 2013-06-06
Status : Active
Type : II
Certificate Number : R1-CEP 2013-212 - Rev 00
Issue Date : 2020-04-28
Type : Chemical
Substance Number : 542
Status : Valid
NDC Package Code : 46014-1116
Start Marketing Date : 2014-06-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-29
Pay. Date : 2014-01-22
DMF Number : 25433
Submission : 2011-12-29
Status : Active
Type : II
Certificate Number : R1-CEP 2013-341 - Rev 01
Issue Date : 2023-08-31
Type : Chemical
Substance Number : 542
Status : Valid
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
NDC Package Code : 14593-865
Start Marketing Date : 2023-12-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-02
Pay. Date : 2012-12-19
DMF Number : 25491
Submission : 2011-12-07
Status : Active
Type : II
Certificate Number : R1-CEP 2011-339 - Rev 02
Issue Date : 2022-07-20
Type : Chemical
Substance Number : 542
Status : Valid
Registration Number : 230MF10027
Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India
Initial Date of Registration : 2018-02-15
Latest Date of Registration : --
Date of Issue : 2019-07-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0147
Address of the Firm :
NDC Package Code : 82920-008
Start Marketing Date : 2022-08-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21126
Submission : 2007-12-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25836
Submission : 2012-04-01
Status : Inactive
Type : IV
NDC Package Code : 14593-865
Start Marketing Date : 2023-12-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25393
Submission : 2011-10-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24385
Submission : 2010-11-30
Status : Inactive
Type : II
Registrant Name : Fresenius Kabi Korea Co., Ltd.
Registration Date : 2018-07-26
Registration Number : 20180726-210-J-248
Manufacturer Name : Fresenius Kabi Oncology Ltd.
Manufacturer Address : D-35, Industrial Area, Kalyani, Dist Nadia, West Bengal, INDIA
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