Chongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.
01 1Chongqing Sintaho Pharmaceutical
02 2Dr. Reddy's Laboratories
03 1Transo-Pharm USA LLC
04 1Shanghai Minbiotech
05 1ALP Pharm
06 1Alphora Research
07 1BrightGene Bio-Medical Technology Co.,Ltd
08 1Eisai
09 1Emcure Pharmaceuticals
10 1Formosa Laboratories
11 1Guangzhou Tosun Pharmaceutical
12 1Hetero Drugs
13 2Jiangsu Zenji Pharmaceuticals,Ltd.
14 1Lianyungang Runzhong Pharmaceutical Co Ltd
15 1Mac-Chem Products (India) Pvt.Ltd
16 1Natco Pharma
17 1Suzhou Tianma Pharma Group Co Ltd
18 1Wisdom Pharmaceutical
19 1Xiling Lab
20 1Yonsung Fine Chemicals
21 1Zhejiang Raybow Pharma
01 1Canada
02 11China
03 6India
04 1Japan
05 1South Korea
06 1Taiwan
07 2U.S.A
01 15Active
02 8Blank
01 23Blank
01 1301MF10104
02 1304MF10030
03 21Blank
01 23Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-13
Pay. Date : 2023-09-22
DMF Number : 37559
Submission : 2023-01-31
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35948
Submission : 2021-05-27
Status : Active
Type : II
NDC Package Code : 71796-044
Start Marketing Date : 2021-11-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-02-03
Pay. Date : 2021-12-17
DMF Number : 36433
Submission : 2021-11-30
Status : Active
Type : II
NDC Package Code : 71796-044
Start Marketing Date : 2021-11-30
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 : 36566
Submission : 2021-12-28
Status : Active
Type : II
NDC Package Code : 14593-945
Start Marketing Date : 2021-03-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10g/10g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-20
Pay. Date : 2022-09-28
DMF Number : 37388
Submission : 2022-09-02
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-04-03
Pay. Date : 2023-01-11
DMF Number : 37740
Submission : 2023-01-07
Status : Active
Type : II
NDC Package Code : 61662-0019
Start Marketing Date : 2023-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34819
Submission : 2020-08-06
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-02-15
Pay. Date : 2022-01-11
DMF Number : 36605
Submission : 2022-01-06
Status : Active
Type : II
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