Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Seqens
03 1Dr. Reddy's Laboratories
04 1Chromo Laboratories
05 1Cipla
06 1Fujian South Pharmaceutical
07 1Hubei Haosun Pharmaceutical Co., Ltd.
08 1Mehta Pharmaceutical Industries
09 1Sakar Healthcare
10 1Swati Spentose
11 1Syn-Tech Chem. & Pharm
12 1Zhejiang Hisun Pharmaceutical
01 3China
02 1France
03 6India
04 1Spain
05 1Taiwan
01 6Active
02 1Inactive
03 5Blank
01 12Blank
01 12Blank
01 1WC-0067
02 1WC-0113
03 1WC-0317A2
04 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21790
Submission : 2008-06-24
Status : Active
Type : II
NDC Package Code : 64567-0010
Start Marketing Date : 2009-08-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22311
Submission : 2008-12-15
Status : Active
Type : II
NDC Package Code : 58175-0537
Start Marketing Date : 2006-04-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23128
Submission : 2009-09-25
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 55111-841
Start Marketing Date : 2009-09-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sangjin Corporation
Registration Date : 2013-03-05
Registration Number : 20130305-177-I-125-01
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : APIIC Industrial Estate, Pydibheemavaram Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-29
Pay. Date : 2015-03-20
DMF Number : 25980
Submission : 2012-04-16
Status : Active
Type : II
NDC Package Code : 54871-1091
Start Marketing Date : 2012-07-25
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 : 18820
Submission : 2005-09-28
Status : Active
Type : II
Date of Issue : 2022-06-20
Valid Till : 2025-08-08
Written Confirmation Number : WC-0113
Address of the Firm :
NDC Package Code : 53104-7609
Start Marketing Date : 2018-09-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
Registrant Name : LG Chemical Co., Ltd.
Registration Date : 2012-10-11
Registration Number : 20111118-177-I-11-10(1)
Manufacturer Name : Cipla Limited
Manufacturer Address : Virgonagar Post, Old Madras Road, Bangalore-560 049, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22089
Submission : 2008-09-29
Status : Active
Type : II
NDC Package Code : 14778-0202
Start Marketing Date : 2011-10-10
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 : 16470
Submission : 2003-03-10
Status : Inactive
Type : II
Date of Issue : 2020-11-27
Valid Till : 2021-06-07
Written Confirmation Number : WC-0317A2
Address of the Firm :
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