Inke S.A: APIs manufacturing plant.

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01 1Inke S.A
02 1Vamsi Labs
03 1LGM Pharma
04 1Seqens
05 1Jai Radhe Sales
06 1Shanghai Minbiotech
07 1Tenatra Exports
08 1TAPI Technology & API Services
09 1ALP Pharm
10 1ALPS Pharmaceutical Ind. Co. Ltd.
11 1Aspire Lifesciences Pvt Ltd
12 1Beijing Breathgreen Healthcare
13 1Beijing Fukangren Biopharmaceutical
14 1Boehringer Ingelheim GmbH
15 1Breathgreen Pharmaceuticals
16 1CHEMO
17 1Cipla
18 1DEAFARMA
19 1Deva Holding AS
20 1Guangzhou Topwork Chemical
21 1Guangzhou Tosun Pharmaceutical
22 3Industriale Chimica
23 1Jayco Chemical Industries
24 1Kyongbo Pharmaceutical Co., Ltd
25 1Lianyungang Runzhong Pharmaceutical Co Ltd
26 1Lupin Ltd
27 1Lusochimica
28 1Melody Healthcare
29 1Micro Orgo Chem
30 1Polaris AI Pharma
31 1Protheragen
32 1Teva Pharmaceutical Industries
33 1Tocopharm Co. Limited
34 1Vital Laboratories Private Limited
35 1Zhejiang Xianju Pharmaceutical Co. Ltd
36 2Blank
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01 10China
02 1France
03 1Germany
04 10India
05 2Israel
06 5Italy
07 1Japan
08 2South Korea
09 2Spain
10 1Turkey
11 2U.S.A
12 2Blank
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01 8Active
02 31Blank
01 10Valid
02 29Blank
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01 1221MF10173
02 38Blank
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01 1WC-0144
02 1WC-0155
03 37Blank
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01 39Blank
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01 112714-915
02 160722-1012
03 161662-0021
04 163190-0380
05 163190-0560
06 163190-0640
07 164567-0026
08 166412-0761
09 31Blank
01 39Blank
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 : CEP 2019-337 - Rev 02
Issue Date : 2025-10-24
Type : Chemical
Substance Number : 2420
Status : Valid
NDC Package Code : 64567-0026
Start Marketing Date : 2021-01-20
End Marketing Date : 2025-12-31
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 03
Issue Date : 2025-06-25
Type : Chemical
Substance Number : 2420
Status : Valid
Date of Issue : 2025-11-12
Valid Till : 2028-07-02
Written Confirmation Number : WC-0155
Address of the Firm :
NDC Package Code : 66412-0761
Start Marketing Date : 2020-04-20
End Marketing Date : 2025-12-31
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, & custom-made solutions to our customers.
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
| Available Reg Filing : ASMF |
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41034
Submission : 2024-12-24
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2025-10-24
Pay. Date : 2025-08-26
DMF Number : 40993
Submission : 2025-07-22
Status : Active
Type : II

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