Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Vamsi Labs
03 1LGM Pharma
04 1Seqens
05 1Jai Radhe Sales
06 1ALP Pharm
07 1ALPS Pharmaceutical Ind. Co. Ltd.
08 1Alkaloids Corporation
09 1Aspire Lifesciences Pvt Ltd
10 1Beijing Breathgreen Healthcare
11 1Beijing Fukangren Biopharmaceutical
12 2Boehringer Ingelheim GmbH
13 1CHEMO
14 2Cerbios-Pharma SA
15 1Cipla
16 1DEAFARMA
17 1Deva Holding AS
18 1Estechpharma
19 1Guangzhou Topwork Chemical
20 1Guangzhou Tosun Pharmaceutical
21 1Industriale Chimica
22 1Jayco Chemical Industries
23 1Jewim Pharmaceutical
24 1Kyongbo Pharmaceutical Co., Ltd
25 1Lianyungang Runzhong Pharmaceutical Co Ltd
26 1Lupin Ltd
27 1Lusochimica
28 2Melody Healthcare Pvt Ltd
29 1Olon S.p.A
30 1R L Fine Chem
31 1Resonance Laboratories Pvt. Ltd
32 1Teva API
33 1Teva Pharmaceutical Industries
34 1Tocopharm Co. Limited
35 1Vital Laboratories Private Limited
36 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 9China
02 1France
03 2Germany
04 12India
05 2Israel
06 4Italy
07 1Japan
08 2South Korea
09 2Spain
10 2Switzerland
11 1Turkey
12 1U.S.A
01 8Active
02 2Inactive
03 29Blank
01 10Valid
02 29Blank
01 1221MF10173
02 38Blank
01 1WC-0144
02 1WC-0155
03 1WC-0227
04 1WC-0227A3
05 35Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-04-30
Pay. Date : 2020-01-13
DMF Number : 34410
Submission : 2020-03-17
Status : Active
Type : II
Certificate Number : R0-CEP 2019-337 - Rev 01
Issue Date : 2023-05-16
Type : Chemical
Substance Number : 2420
Status : Valid
NDC Package Code : 64567-0026
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 : CN |
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-11
Pay. Date : 2020-11-04
DMF Number : 34808
Submission : 2020-04-15
Status : Active
Type : II
Certificate Number : CEP 2012-285 - Rev 02
Issue Date : 2024-01-16
Type : Chemical
Substance Number : 2420
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 : 66412-0761
Start Marketing Date : 2020-04-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-16
Pay. Date : 2013-12-31
DMF Number : 28161
Submission : 2013-12-26
Status : Active
Type : II
Certificate Number : CEP 2014-271 - Rev 02
Issue Date : 2024-10-23
Type : Chemical
Substance Number : 2420
Status : Valid
NDC Package Code : 58175-0565
Start Marketing Date : 2011-12-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-12-07
Pay. Date : 2023-07-27
DMF Number : 27120
Submission : 2013-04-30
Status : Active
Type : II
Certificate Number : R1-CEP 2016-326 - Rev 01
Issue Date : 2022-12-08
Type : Chemical
Substance Number : 2420
Status : Valid
NDC Package Code : 63190-0380
Start Marketing Date : 2011-07-04
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-03
Pay. Date : 2015-02-05
DMF Number : 28820
Submission : 2015-01-27
Status : Active
Type : II
NDC Package Code : 54239-011
Start Marketing Date : 2014-10-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : MediHelpline Co., Ltd.
Registration Date : 2019-08-01
Registration Number : 20190801-211-J-399
Manufacturer Name : Cerbios Pharma SA@[Spray Drying Plant] Micro-Sphere SA
Manufacturer Address : Via Figino 6, 6917 Barbengo, Switzerland@[Spray drying factory]Via Cantonale 77, 6998 Monteggio, Switzerland
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36281
Submission : 2021-10-01
Status : Active
Type : II
NDC Package Code : 54239-011
Start Marketing Date : 2014-10-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : MediHelpline Co., Ltd.
Registration Date : 2019-08-01
Registration Number : 20190801-211-J-399
Manufacturer Name : Cerbios Pharma SA@[Spray Drying Plant] Micro-Sphere SA
Manufacturer Address : Via Figino 6, 6917 Barbengo, Switzerland@[Spray drying factory]Via Cantonale 77, 6998 Monteggio, Switzerland
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-20
Pay. Date : 2015-11-19
DMF Number : 29726
Submission : 2016-01-20
Status : Active
Type : II
Certificate Number : R0-CEP 2019-126 - Rev 00
Issue Date : 2021-04-13
Type : Chemical
Substance Number : 2420
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-15
Pay. Date : 2013-09-17
DMF Number : 27524
Submission : 2013-10-23
Status : Active
Type : II
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