Veranova: A CDMO that manages complexity with confidence.
01 1Veranova
02 1Parand Darou Pharma
03 1Alkaloida Chemical Company Zrt
04 1Biotechnica DWC
05 1Chattem Chemicals, Inc
06 1DMFs Not Supported
07 1Hasti Aria Shimi
08 1Kimyagaran
09 2Mallinckrodt Pharmaceuticals
10 1SALARAS
11 1Saneca Pharmaceuticals
12 1Siegfried AG
01 1Algeria
02 1Hungary
03 3Iran
04 2Ireland
05 1Italy
06 1Slovakia
07 1Switzerland
08 2U.S.A
09 1Blank
01 2Active
02 2Inactive
03 9Blank
01 4Valid
02 9Blank
01 13Blank
01 13Blank
Certificate Number : R1-CEP 2003-209 - Rev 01
Issue Date : 2015-02-13
Type : Chemical
Substance Number : 1776
Status : Valid
Registrant Name : Baeksu Pharmaceutical Co., Ltd.
Registration Date : 2021-03-10
Registration Number : 20210310-209-J-865(A)
Manufacturer Name : Macfarlan Smith Limited
Manufacturer Address : 10 Wheatfield Road, Edinburgh, EH11 2QA, United Kingdom
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-10-24
Pay. Date : 2012-12-04
DMF Number : 191
Submission : 1956-01-24
Status : Active
Type : II
NDC Package Code : 0406-1578
Start Marketing Date : 2013-11-20
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 : 32354
Submission : 2019-09-27
Status : Active
Type : II
NDC Package Code : 61960-0100
Start Marketing Date : 2018-12-17
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 : 6009
Submission : 1985-09-27
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 207
Submission : 1956-05-09
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 0406-1578
Start Marketing Date : 2013-11-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2009-225 - Rev 02
Issue Date : 2020-08-21
Type : Chemical
Substance Number : 1776
Status : Valid
Registrant Name : Baeksu Pharmaceutical Co., Ltd.
Registration Date : 2021-09-07
Registration Number : 20210511-209-J-706(1)
Manufacturer Name : Alkaloida Chemical Company Zrt.
Manufacturer Address : Kabay Janos u.29., Tiszavasvari, 4440, Hungary
Certificate Number : R1-CEP 2004-187 - Rev 01
Issue Date : 2011-04-08
Type : Chemical
Substance Number : 1776
Status : Valid
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