Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
01 1Aarti Pharmalabs
02 2Dr. Reddy's Laboratories
03 1Shandong Chenghui Shuangda Pharmaceutical
04 1Hubei Gedian Humanwell Pharmaceutical
05 1Porton Pharma Solutions
06 1Alembic Pharmaceuticals Limited
07 1Aurisco Pharmaceutical
08 1Aurobindo Pharma Limited
09 1Beijing Hope Pharmaceutical
10 1Beijing Mesochem Technology
11 1BrightGene Bio-Medical Technology Co.,Ltd
12 1Cipla
13 1Fujian South Pharmaceutical
14 1Hetero Drugs
15 1Laurus Labs
16 2MSN Laboratories
17 1Prajna Generics
18 1Shandong Boyuan Pharmaceutical
19 1Shandong Haohong Biotechnology Co.,ltd
20 1Shanghai Hope Chem
21 1Shenzhen HwaGen Pharmaceutical
22 1Sichuan Qingmu Pharmaceutical
23 1TAPI Technology & API Services
24 1Vannsh Life Sciences
25 1Viatris
26 1Zhejiang Tianyu Pharmaceutical Co., Ltd
27 1Zydus Lifesciences
01 14China
02 13India
03 1Israel
04 1U.S.A
01 11Active
02 18Blank
01 29Blank
01 29Blank
01 1WC-0082
02 1WC-0349
03 1WC-0349A12
04 1WC-0390
05 25Blank
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-10-28
Pay. Date : 2020-09-30
DMF Number : 34667
Submission : 2020-03-24
Status : Active
Type : II
Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm :
NDC Package Code : 71796-019
Start Marketing Date : 2020-03-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Shuangda Pharmaceutical has a world-class first-class production line, having GMP, FDA and other regulatory certifications.
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39029
Submission : 2023-11-02
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 : 35740
Submission : 2021-03-25
Status : Active
Type : II
NDC Package Code : 71796-019
Start Marketing Date : 2020-03-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-12-29
Pay. Date : 2021-11-17
DMF Number : 36394
Submission : 2021-11-24
Status : Active
Type : II
NDC Package Code : 68554-0127
Start Marketing Date : 2018-02-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-10
Pay. Date : 2021-09-24
DMF Number : 34711
Submission : 2020-03-31
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 : 54893-0100
Start Marketing Date : 2020-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-12-29
Pay. Date : 2021-12-07
DMF Number : 36264
Submission : 2021-09-09
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-02
Pay. Date : 2021-09-20
DMF Number : 36028
Submission : 2021-09-22
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
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