Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Neuland Laboratories
03 1LGM Pharma
04 1Metrochem API Private Limited
05 1Vamsi Labs
06 1TAPI Technology & API Services
07 1Beijing Breathgreen Healthcare
08 1CHEMO
09 1Cipla
10 1GSK
11 1Guangdong Raffles PharmaTech Co Ltd
12 1Harman Finochem
13 1Hovione
14 1Hunan Huateng Pharmaceutical Co ltd
15 1Jayco Chemical Industries
16 1Lupin Ltd
17 2MSN Laboratories
18 1Melody Healthcare Pvt Ltd
19 1Natco Pharma
20 1R L Fine Chem
21 1Shenzhen HwaGen Pharmaceutical
22 1Sterling Chemical Malta
23 1Sterling Spa
24 1Teva Pharmaceutical Industries
01 4China
02 12India
03 2Israel
04 1Italy
05 1Malta
06 1Portugal
07 2Spain
08 1U.S.A
09 1United Kingdom
01 8Active
02 17Blank
01 25Blank
01 25Blank
01 1WC-0021A4
02 1WC-0021n
03 1WC-0036
04 1WC-0227n
05 21Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-19
Pay. Date : 2023-01-09
DMF Number : 35498
Submission : 2023-03-16
Status : Active
Type : II
NDC Package Code : 64567-0027
Start Marketing Date : 2021-01-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36450
Submission : 2022-01-07
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
Available Reg Filing : ASMF |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25906
Submission : 2012-06-19
Status : Active
Type : II
NDC Package Code : 52482-009
Start Marketing Date : 2014-06-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2014-06-30
Registration Number : Su2480-12-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 : 39842
Submission : 2024-04-15
Status : Active
Type : II
NDC Package Code : 59057-016
Start Marketing Date : 2023-05-26
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 : 39385
Submission : 2024-02-11
Status : Active
Type : II
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