Axplora- The partner of choice for complex APIs.
01 3Axplora
02 1Coral Drugs Private Limited
03 1Gonane Pharma
04 1EUROAPI
05 1Sanofi
06 1LGM Pharma
07 1Inabata France S.A.S
08 3Symbiotec Pharmalab
09 1Jai Radhe Sales
10 1Vamsi Labs
11 1HRV Global Life Sciences
12 1Atman Pharmaceuticals
13 1ACS DOBFAR SPA
14 1Avik Pharmaceutical Limited
15 3Bristol Myers Squibb
16 2Curia
17 1Envee Drugs
18 1Fujifilm Diosynth Biotechnologies
19 1Guangzhou Topwork Chemical
20 1Gyma Laboratories of America, Inc.
21 1Henan Lihua Pharmaceutical
22 1Maharshi Pharma Chem
23 1Mahima Life Sciences
24 1Micro Orgo Chem
25 1NEWCHEM SPA
26 1Pfizer Inc
27 1Pierrel
28 1Qingdao Qingmei Biotech
29 1Quimica Sintetica
30 1SM BIOMED
31 1Shandong Sito Bio-technology Co ltd
32 1Sicor Societa Italiana Corticosteroidi Srl
33 1Swati Spentose
34 1Tecoland Corporation
35 2Teva API
36 1Teva Pharmaceutical Industries
37 1Tianjin Pacific Chemical & Pharmaceutical Co., Ltd
38 1Tianjin Tianyao Pharmaceuticals Co., Ltd.
39 1Vaishali Pharma Ltd
40 1Zhejiang Xianju Pharmaceutical Co. Ltd
41 5Blank
01 7China
02 3France
03 3Germany
04 16India
05 3Israel
06 4Italy
07 1Malaysia
08 1Spain
09 9U.S.A
10 1United Kingdom
11 5Blank
01 12Active
02 16Inactive
03 25Blank
01 9Valid
02 1Withdrawn by Holder
03 43Blank
01 1218MF10531
02 1220MF10216
03 1221MF10001
04 1223MF10049
05 1305MF10085
06 48Blank
01 1WC-0009
02 1WC-0161
03 1WC-0161A2
04 1WC-0162
05 1WC-0169
06 1WC-0485
07 47Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-21
Pay. Date : 2013-05-14
DMF Number : 14693
Submission : 2000-02-01
Status : Active
Type : II
Certificate Number : R0-CEP 2021-315 - Rev 00
Issue Date : 2021-12-21
Type : Chemical
Substance Number : 533
Status : Valid
Registration Number : 305MF10085
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2023-07-19
Latest Date of Registration : --
NDC Package Code : 46439-8703
Start Marketing Date : 1999-02-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2019-12-09
Registration Number : 20150130-65-B-382-10(1)
Manufacturer Name : Farmabios SpA
Manufacturer Address : Via Pavia 1-27027 Gropello Cairoli (PV), Italy
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-14
Pay. Date : 2019-07-23
DMF Number : 31357
Submission : 2017-02-06
Status : Active
Type : II
Certificate Number : CEP 2017-167 - Rev 02
Issue Date : 2024-05-27
Type : Chemical
Substance Number : 533
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-07-05
Written Confirmation Number : WC-0009
Address of the Firm :
NDC Package Code : 49076-6701
Start Marketing Date : 2018-04-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pami Future Co., Ltd.
Registration Date : 2021-12-17
Registration Number : 20211217-65-B-461-11
Manufacturer Name : Coral Drugs Private Limited
Manufacturer Address : 55-57, HSIIDC Industrial Estate, Murthal, District - Sonepat Haryana, India
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22947
Submission : 2009-07-15
Status : Active
Type : II
NDC Package Code : 82298-123
Start Marketing Date : 2011-02-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Opella Healthcare Korea Co., Ltd.
Registration Date : 2012-05-25
Registration Number : 20120525-65-B-330-07
Manufacturer Name : EuroAPI France
Manufacturer Address : 4 Lieu Dit La Paterie, Vertolaye, 63480, France
Available Reg Filing : ASMF, ROW |
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 : 4085
Submission : 1981-03-03
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-15
Pay. Date : 2013-02-28
DMF Number : 21263
Submission : 2008-01-23
Status : Active
Type : II
Certificate Number : R1-CEP 2008-032 - Rev 04
Issue Date : 2023-04-06
Type : Chemical
Substance Number : 533
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 : 22552-0003
Start Marketing Date : 2017-02-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hiple Co., Ltd.
Registration Date : 2021-11-12
Registration Number : 20121126-65-B-324-08(4)
Manufacturer Name : Symbiotec Pharmalab Pvt. Limited
Manufacturer Address : 385/2 Gram Pigdamber, Near Hotel Mashal, Off AB Road, Rau, Indore-453 331 (MP) India
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
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