Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ChemWerth Inc
03 1LGM Pharma
04 1Gonane Pharma
05 1Atomgrid
06 1Guangzhou Topwork Chemical
07 1Maharshi Pharma Chem
08 1Sicor Societa Italiana Corticosteroidi Srl
09 1Steroid SpA
10 1TAPI Technology & API Services
11 1Teva Pharmaceutical Industries
12 1Tianjin Pacific Chemical & Pharmaceutical Co., Ltd
01 2China
02 1Germany
03 3India
04 2Israel
05 2Italy
06 2U.S.A
01 4Active
02 8Blank
01 12Blank
01 1218MF10458
02 1301MF10046
03 10Blank
01 1WC-0485
02 11Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-27
Pay. Date : 2014-04-14
DMF Number : 25228
Submission : 2011-08-23
Status : Active
Type : II
Registration Number : 301MF10046
Registrant's Address : Via Pavia, 1-27027 Gropello Cairoli, Pavia, Italy
Initial Date of Registration : 2019-08-20
Latest Date of Registration : --
NDC Package Code : 46439-8738
Start Marketing Date : 2011-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Available Reg Filing : EU |
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-13
Pay. Date : 2013-08-05
DMF Number : 26378
Submission : 2013-07-22
Status : Active
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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32778
Submission : 2018-05-10
Status : Active
Type : II
NDC Package Code : 49803-002
Start Marketing Date : 2016-02-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25000g/25000g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 26251-0003
Start Marketing Date : 2017-12-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Date of Issue : 2020-09-25
Valid Till : 2023-09-24
Written Confirmation Number : WC-0485
Address of the Firm :
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