Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Gangwal Healthcare
03 1Vamsi Labs
04 1Axplora
05 1LGM Pharma
06 1Fermion Oy
07 1Coral Drugs Private Limited
08 1Jai Radhe Sales
09 1Aarti Pharmalabs
10 1Neuland Laboratories
11 1Tenatra Chemie
12 1Porton Pharma Solutions
13 1Amphastar Pharmaceuticals
14 1Aspire Lifesciences Pvt Ltd
15 1Asymchem Laboratories
16 1CHEMO
17 3Cipla
18 1DEAFARMA
19 1GSK
20 1Guangzhou Tosun Pharmaceutical
21 1Hasti Aria Shimi
22 2Hovione
23 1Industriale Chimica
24 1Jayco Chemical Industries
25 1Lab Service
26 1Lunan Pharmaceutical
27 1Lusochimica
28 2MSN Laboratories
29 2Melody Healthcare Pvt Ltd
30 1Natco Pharma
31 1Shouyuan Chemical
32 1Ultratech India Ltd.,
33 1Unipex
34 1Viatris
35 1Zydus Lifesciences
01 5China
02 1Finland
03 2France
04 1Germany
05 19India
06 1Iran
07 3Italy
08 2Portugal
09 2Spain
10 3U.S.A
11 1United Kingdom
01 13Active
02 7Inactive
03 20Blank
01 15Valid
02 1Withdrawn by Holder
03 24Blank
01 1227MF10240
02 39Blank
01 1WC-0009
02 1WC-0014
03 1WC-0021n
04 1WC-0036
05 1WC-0084
06 1WC-0099
07 1WC-0142n
08 1WC-0155
09 1WC-0157
10 1WC-0227n
11 1WC-257
12 29Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-08-12
Pay. Date : 2015-05-20
DMF Number : 23914
Submission : 2010-06-23
Status : Active
Type : II
Certificate Number : R1-CEP 2007-127 - Rev 00
Issue Date : 2014-06-16
Type : Chemical
Substance Number : 1765
Status : Valid
NDC Package Code : 64567-0007
Start Marketing Date : 2008-03-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : CN |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26863
Submission : 2013-02-04
Status : Active
Type : II
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
Certificate Number : CEP 2006-226 - Rev 03
Issue Date : 2024-03-05
Type : Chemical
Substance Number : 1765
Status : Valid
Date of Issue : 2022-06-13
Valid Till : 2025-07-02
Written Confirmation Number : WC-0155
Address of the Firm :
NDC Package Code : 66412-0768
Start Marketing Date : 2023-09-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Certificate Number : R0-CEP 2018-168 - Rev 00
Issue Date : 2020-06-12
Type : Chemical
Substance Number : 1765
Status : Valid
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Certificate Number : CEP 2018-044 - Rev 04
Issue Date : 2024-02-01
Type : Chemical
Substance Number : 1765
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-07-05
Written Confirmation Number : WC-0009
Address of the Firm :
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-05
Pay. Date : 2015-01-05
DMF Number : 22054
Submission : 2008-10-03
Status : Active
Type : II
Certificate Number : R1-CEP 2008-239 - Rev 04
Issue Date : 2022-10-14
Type : Chemical
Substance Number : 1765
Status : Valid
Registration Number : 227MF10240
Registrant's Address : 71, UDYOG KSHETRA, ULND-GOREGAON LINK ROAD, MULUND (W), MUMBAI 400080, INDIA
Initial Date of Registration : 2015-09-29
Latest Date of Registration : --
Date of Issue : 2023-01-06
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm :
NDC Package Code : 15308-1021
Start Marketing Date : 2016-01-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-14
Pay. Date : 2015-12-07
DMF Number : 22973
Submission : 2009-07-22
Status : Active
Type : II
Certificate Number : CEP 2011-277 - Rev 03
Issue Date : 2023-09-12
Type : Chemical
Substance Number : 1765
Status : Valid
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-0143
Start Marketing Date : 2017-12-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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