Axplora- The partner of choice for complex APIs.
01 2Axplora
02 1Symbiotec Pharmalab
03 1Sanofi
04 1LGM Pharma
05 1Gonane Pharma
06 1Jai Radhe Sales
07 1Vamsi Labs
08 1ACS DOBFAR SPA
09 1ALP Pharm
10 1Amphastar Pharmaceuticals
11 1Anuh Pharma LTD
12 1Asia Pioneer Pharmaceuticals
13 1Avik Pharmaceutical Limited
14 1Beijing Breathgreen Healthcare
15 1CHEMO
16 2Cipla
17 1Curia
18 1GSK
19 1Globofarm International
20 1Great Pacific Exports
21 1Grefuel
22 1Halcyon Labs Private Limited
23 1Henan Lihua Pharmaceutical
24 3Hovione
25 1Huvepharma Italia S.r.l
26 2Industriale Chimica
27 1Maharshi Pharma Chem
28 1Mahima Life Sciences
29 1Quimica Sintetica
30 2Rumit Group of Companies
31 1SM BIOMED
32 2Sicor Societa Italiana Corticosteroidi Srl
33 1Steroid SpA
34 1Swati Spentose
35 1Symbiotica Specialty Ingredients
36 3Teva API
37 1Teva Pharmaceutical Industries
38 1Unimax Group
39 1Unipex
40 1Vaishali Pharma Ltd
01 3China
02 2France
03 2Germany
04 19India
05 4Israel
06 7Italy
07 2Malaysia
08 3Portugal
09 2Spain
10 4U.S.A
11 1United Kingdom
01 7Active
02 11Inactive
03 31Blank
01 12Valid
02 37Blank
01 1218MF10532
02 1218MF10626
03 47Blank
01 1WC-0144
02 1WC-0161
03 1WC-0169
04 1WC-241
05 1WC-247
06 44Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-25
Pay. Date : 2019-04-22
DMF Number : 12813
Submission : 1998-01-05
Status : Active
Type : II
Certificate Number : R1-CEP 2001-315 - Rev 02
Issue Date : 2017-06-28
Type : Chemical
Substance Number : 654
Status : Valid
NDC Package Code : 46439-8714
Start Marketing Date : 1993-06-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2013-06-10
Registration Number : 20130610-186-I-285-01
Manufacturer Name : Farmabios SpA
Manufacturer Address : Gropello Cairoli (PV) - Via Pavia, 1, Italy.
Available Reg Filing : CN, SAU |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28137
Submission : 2014-03-20
Status : Active
Type : II
Certificate Number : R1-CEP 2005-062 - Rev 02
Issue Date : 2023-01-27
Type : Chemical
Substance Number : 654
Status : Valid
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161
Address of the Firm :
NDC Package Code : 22552-0038
Start Marketing Date : 2014-01-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8036
Submission : 1989-04-28
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
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 : 21972
Submission : 2008-09-11
Status : Active
Type : II
NDC Package Code : 46439-8714
Start Marketing Date : 1993-06-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Kolon Pharmaceutical Co., Ltd.
Registration Date : 2013-06-10
Registration Number : 20130610-186-I-285-01
Manufacturer Name : Farmabios SpA
Manufacturer Address : Gropello Cairoli (PV) - Via Pavia, 1, Italy.
Available Reg Filing : CN, SAU |
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-01-31
Pay. Date : 2019-01-28
DMF Number : 4871
Submission : 1983-03-14
Status : Active
Type : II
Certificate Number : R1-CEP 2003-254 - Rev 06
Issue Date : 2023-08-17
Type : Chemical
Substance Number : 654
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22648
Submission : 2008-12-09
Status : Inactive
Type : II
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