Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1LGM Pharma
03 1Seqens
04 1TAPI Technology & API Services
05 1Beijing Breathgreen Healthcare
06 1Cipla
07 1GSK
08 1Guangdong Raffles PharmaTech Co Ltd
09 1Guangzhou Topwork Chemical
10 1Harman Finochem
11 1Hikma Pharmaceuticals
12 1Hovione
13 1Jayco Chemical Industries
14 1Lupin Ltd
15 1Melody Healthcare Pvt Ltd
16 1Olon S.p.A
17 1R L Fine Chem
18 1Shenzhen HwaGen Pharmaceutical
19 1Sterling Chemical Malta
20 1Sterling Spa
21 1Teva Pharmaceutical Industries
01 4China
02 1France
03 6India
04 2Israel
05 2Italy
06 1Malta
07 1Portugal
08 1Spain
09 1U.S.A
10 2United Kingdom
01 9Active
02 12Blank
01 21Blank
01 21Blank
01 21Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-07-12
Pay. Date : 2023-01-09
DMF Number : 36482
Submission : 2023-06-16
Status : Active
Type : II
NDC Package Code : 64567-0030
Start Marketing Date : 2022-01-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF, CN |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
NDC Package Code : 58175-0626
Start Marketing Date : 2019-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-12
Pay. Date : 2020-09-08
DMF Number : 32945
Submission : 2018-08-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38002
Submission : 2023-03-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26339
Submission : 2012-11-29
Status : Active
Type : II
NDC Package Code : 52482-012
Start Marketing Date : 2014-08-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2014-07-01
Registration Number : Number 2480-13-ND
Manufacturer Name : Glaxo Wellcome Manufacturing Pte Ltd@[micronization process manufacturing company] Glaxo Operations UK Ltd
Manufacturer Address : 1 Pioneer Sector 1, Singapore 628413@Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39843
Submission : 2024-04-15
Status : Active
Type : II
NDC Package Code : 59057-011
Start Marketing Date : 2022-06-15
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 : 35420
Submission : 2021-04-25
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-30
Pay. Date : 2023-01-13
DMF Number : 37680
Submission : 2023-03-08
Status : Active
Type : II
NDC Package Code : 17337-0434
Start Marketing Date : 2024-06-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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