Axplora- The partner of choice for complex APIs.
01 2Axplora
02 1Symbiotec Pharmalab
03 1Sanofi
04 1LGM Pharma
05 1Coral Drugs Private Limited
06 1Gonane Pharma
07 1Jai Radhe Sales
08 1Vamsi Labs
09 1ACS DOBFAR SPA
10 1ALP Pharm
11 1Amphastar Pharmaceuticals
12 1Anuh Pharma LTD
13 1Asia Pioneer Pharmaceuticals
14 1Avik Pharmaceutical Limited
15 1Beijing Breathgreen Healthcare
16 1CHEMO
17 2Cipla
18 1Curia
19 1GSK
20 1Globofarm International
21 1Great Pacific Exports
22 1Grefuel
23 1Halcyon Labs Private Limited
24 1Henan Lihua Pharmaceutical
25 3Hovione
26 1Huvepharma Italia S.r.l
27 2Industriale Chimica
28 1Maharshi Pharma Chem
29 1Mahima Life Sciences
30 1Quimica Sintetica
31 2Rumit Group of Companies
32 1SM BIOMED
33 2Sicor Societa Italiana Corticosteroidi Srl
34 1Steroid SpA
35 1Swati Spentose
36 1Symbiotica Specialty Ingredients
37 3Teva API
38 1Teva Pharmaceutical Industries
39 1Unimax Group
40 1Unipex
41 1Vaishali Pharma Ltd
01 3China
02 2France
03 2Germany
04 20India
05 4Israel
06 7Italy
07 2Malaysia
08 3Portugal
09 2Spain
10 4U.S.A
11 1United Kingdom
01 7Active
02 11Inactive
03 32Blank
01 12Valid
02 38Blank
01 1218MF10532
02 1218MF10626
03 48Blank
01 1WC-0144
02 1WC-0161
03 1WC-0169
04 1WC-241
05 1WC-247
06 45Blank
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 22648
Submission : 2008-12-09
Status : Inactive
Type : II
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