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 1TAPI Technology & API Services
07 1Alembic Pharmaceuticals Limited
08 1Aurisco Pharmaceutical
09 1Aurobindo Pharma Limited
10 1Beijing Hope Pharmaceutical
11 1Beijing Mesochem Technology
12 1BrightGene Bio-Medical Technology Co.,Ltd
13 1Cipla
14 1Fujian South Pharmaceutical
15 1Hetero Drugs
16 1Laurus Labs
17 2MSN Laboratories
18 1Prajna Generics
19 1Shandong Haohong Biotechnology Co.,ltd
20 1Shanghai Hope Chem
21 1Shenzhen HwaGen Pharmaceutical
22 1Sichuan Qingmu Pharmaceutical
23 1Vannsh Life Sciences
24 1Viatris
25 1Zhejiang Tianyu Pharmaceutical Co., Ltd
26 1Zydus Lifesciences
01 13China
02 13India
03 1Israel
04 1U.S.A
01 11Active
02 17Blank
01 28Blank
01 28Blank
01 1WC-0082
02 1WC-0349
03 1WC-0349A12
04 1WC-0390
05 24Blank
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 40362
Submission : 2024-08-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39890
Submission : 2024-05-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-09-29
Pay. Date : 2021-08-19
DMF Number : 36165
Submission : 2021-09-14
Status : Active
Type : II
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