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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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01 1HRV Global Life Sciences
02 1ACS DOBFAR SPA
03 1ADL BioPharma
04 1Amifarma S.L. ES 08389 Palafolls Barcelona
05 2Aurobindo Pharma Limited
06 1Fresenius Kabi AB Brunna
07 2GSK
08 1Istituto Biochimico Italiano Giovanni Lorenzini SpA
09 1Rajasthan Antibiotics
10 2Sandoz B2B
11 1Sterile India Pvt. Ltd
12 1Teva API
13 1Zhuhai United Laboratories Co ., Ltd.
01 1China
02 5India
03 1Israel
04 2Italy
05 2Spain
06 1Sweden
07 2Switzerland
08 2United Kingdom
01 3Active
02 4Inactive
03 9Blank
01 7Valid
02 1Withdrawn by Holder
03 8Blank
01 16Blank
01 1WC-0121
02 1WC-0378A2
03 14Blank
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-01-05
Pay. Date : 2023-11-28
DMF Number : 39198
Submission : 2023-12-01
Status : Active
Type : II
NDC Package Code : 59651-883
Start Marketing Date : 2023-11-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18044
Submission : 2005-02-01
Status : Active
Type : II
Certificate Number : CEP 1998-058 - Rev 07
Issue Date : 2024-03-13
Type : Chemical
Substance Number : 577
Status : Valid
Registrant Name : Penmix Co., Ltd.
Registration Date : 2013-05-02
Registration Number : 20101116-30-A-240-15(3)
Manufacturer Name : Sandoz GmbH
Manufacturer Address : Biochemiestrasse 10, A-6250 Kundl, Tyrol
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38349
Submission : 2023-05-17
Status : Active
Type : II
Certificate Number : R1-CEP 2008-267 - Rev 07
Issue Date : 2022-10-11
Type : Chemical
Substance Number : 577
Status : Valid
NDC Package Code : 66558-0200
Start Marketing Date : 2021-11-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5308
Submission : 1984-02-29
Status : Inactive
Type : II
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2014-04-21
Registration Number : 20140421-30-A-291-19
Manufacturer Name : SmithKline Beecham Pharmaceuticals@[Starting Material (Amoxicillin Trihydrate) Manufacturer] Beecham Pharmaceuticals (Pte) Ltd
Manufacturer Address : Clarendon Road, Worthing, West Sussex, BN14 8QH, United Kingdom@38 Quality Road, Jurong Industrial Estate, Singapore 618809
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24471
Submission : 2011-02-11
Status : Inactive
Type : II
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2014-04-21
Registration Number : 20140421-30-A-291-19
Manufacturer Name : SmithKline Beecham Pharmaceuticals@[Starting Material (Amoxicillin Trihydrate) Manufacturer] Beecham Pharmaceuticals (Pte) Ltd
Manufacturer Address : Clarendon Road, Worthing, West Sussex, BN14 8QH, United Kingdom@38 Quality Road, Jurong Industrial Estate, Singapore 618809
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20128
Submission : 2006-12-30
Status : Inactive
Type : II
Certificate Number : CEP 2008-002 - Rev 03
Issue Date : 2023-11-30
Type : Chemical
Substance Number : 577
Status : Valid
Date of Issue : 2019-07-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0121
Address of the Firm :
NDC Package Code : 59651-883
Start Marketing Date : 2023-11-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18259
Submission : 2005-04-08
Status : Inactive
Type : II
Certificate Number : CEP 1996-013 - Rev 09
Issue Date : 2024-01-19
Type : Chemical
Substance Number : 577
Status : Valid
Certificate Number : R1-CEP 1998-069 - Rev 01
Issue Date : 2009-06-17
Type : Chemical
Substance Number : 577
Status : Valid
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