Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ChemWerth Inc
03 1LGM Pharma
04 1Gonane Pharma
05 1TAPI Technology & API Services
06 1Atomgrid
07 1Guangzhou Topwork Chemical
08 1Maharshi Pharma Chem
09 1Sicor Societa Italiana Corticosteroidi Srl
10 1Steroid SpA
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 : Reviewed
Rev. Date : 2015-10-26
Pay. Date : 2015-10-21
DMF Number : 19870
Submission : 2006-10-16
Status : Active
Type : II
Available Reg Filing : CA, ASMF |
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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