Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Aspen API
03 1Shandong Chenghui Shuangda Pharmaceutical
04 1Omgene Life Sciences Pvt. Ltd
05 1Curia
06 1Guangzhou Topwork Chemical
07 1TAPI Technology & API Services
08 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 3China
02 1Germany
03 1India
04 1Israel
05 1Netherlands
06 1U.S.A
01 2Active
02 6Blank
01 8Blank
01 8Blank
01 8Blank
Axplora- The partner of choice for complex APIs.
Aspen API. More than just an API.
Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39854
Submission : 2024-04-16
Status : Active
Type : II
NDC Package Code : 60722-3015
Start Marketing Date : 2022-07-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-06-03
Pay. Date : 2020-05-15
DMF Number : 34802
Submission : 2020-04-24
Status : Active
Type : II
NDC Package Code : 65089-0060
Start Marketing Date : 2021-02-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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