Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
01 1Porton Pharma Solutions
02 1Transo-Pharm USA LLC
03 1Egis Pharmaceuticals PLC
04 1Shandong Chenghui Shuangda Pharmaceutical
05 1Sichuan Elixir Pharmaceuticals
06 1Beijing Mesochem Technology
07 1Beijing Sjar Technology Development
08 1Cdymax
09 1Divis Laboratories
10 1Fresenius Kabi Oncology Limited
11 1Hangzhou Longshine Bio-Tech
12 1Hetero Drugs
13 1Hunan Huateng Pharmaceutical Co ltd
14 1MSN Laboratories
15 1Natco Pharma
16 1Shandong Haohong Biotechnology Co.,ltd
17 1Sun Pharmaceutical Industries Limited
01 8China
02 1Hungary
03 7India
04 1U.S.A
01 5Active
02 1Inactive
03 11Blank
01 17Blank
01 17Blank
01 1WC-0115A3
02 1WC-0349
03 15Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40093
Submission : 2024-06-13
Status : Active
Type : II
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-06-28
Pay. Date : 2022-03-15
DMF Number : 36908
Submission : 2022-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39383
Submission : 2024-01-30
Status : Active
Type : II
NDC Package Code : 68554-0150
Start Marketing Date : 2015-12-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-07-19
Pay. Date : 2019-05-28
DMF Number : 33637
Submission : 2019-02-28
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0087
Start Marketing Date : 2019-02-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33869
Submission : 2019-06-12
Status : Inactive
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-09-15
Written Confirmation Number : WC-0115A3
Address of the Firm :
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