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 1Olon S.p.A
18 1Prajna Generics
19 1Shandong Boyuan Pharmaceutical
20 1Shandong Haohong Biotechnology Co.,ltd
21 1Shanghai Hope Chem
22 1Shenzhen HwaGen Pharmaceutical
23 1Sichuan Qingmu Pharmaceutical
24 1Teva API
25 1Vannsh Life Sciences
26 1Viatris
27 1Zhejiang Tianyu Pharmaceutical Co., Ltd
28 1Zydus Lifesciences
29 1Blank
01 14China
02 13India
03 1Israel
04 1Italy
05 1U.S.A
06 1Blank
01 11Active
02 20Blank
01 31Blank
01 31Blank
01 1WC-0082
02 1WC-0349
03 1WC-0349A12
04 1WC-0390
05 27Blank
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 : 2021-09-29
Pay. Date : 2021-08-19
DMF Number : 36165
Submission : 2021-09-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39890
Submission : 2024-05-05
Status : Active
Type : II
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