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 1Beijing Breathgreen Healthcare
07 1CHEMO
08 1Cipla
09 1GSK
10 1Guangdong Raffles PharmaTech Co Ltd
11 1Harman Finochem
12 1Hovione
13 1Hunan Huateng Pharmaceutical Co ltd
14 1Jayco Chemical Industries
15 1Lupin Ltd
16 2MSN Laboratories
17 1Melody Healthcare Pvt Ltd
18 1Natco Pharma
19 1R L Fine Chem
20 1Shenzhen HwaGen Pharmaceutical
21 1Sterling Chemical Malta
22 1Sterling Spa
23 1TAPI Technology & API Services
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-0227
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 : 34083
Submission : 2019-10-05
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0095
Start Marketing Date : 2019-10-04
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 : 37700
Submission : 2022-11-22
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-07-02
Written Confirmation Number : WC-0227
Address of the Firm :
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
Date of Issue : 2022-01-04
Valid Till : 2022-07-14
Written Confirmation Number : WC-0021A4
Address of the Firm :
NDC Package Code : 14501-0095
Start Marketing Date : 2019-10-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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