Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
01 1Shandong Loncom Pharmaceutical
02 1Macsen Labs
03 1Alkem Laboratories
04 1Aspire Lifesciences Pvt Ltd
05 1Boehringer Ingelheim GmbH
06 1Fareva
07 2Fuji Chemical Industry
08 1Fujian South Pharmaceutical
09 1Guangzhou Tosun Pharmaceutical
10 1Hunan Warrant Chiral Pharmaceutical
11 1Jiangsu Zenji Pharmaceuticals,Ltd.
12 1Natco Pharma
13 1Signa S.A. de C.V.
14 2Solara Active Pharma Sciences
15 1Sumitomo Chemical
16 1Swati Spentose
17 1Symed Labs
18 1Unimark Remedies Limited
19 2Viatris
20 1Zhejiang East Asia Pharmaceutical
21 1Zhejiang Guobang Pharmaceutical
22 1Zhuhai Rundu Pharmaceutical
01 8China
02 1Germany
03 9India
04 3Japan
05 1Luxembourg
06 1Mexico
07 2U.S.A
01 11Active
02 2Inactive
03 12Blank
01 25Blank
01 1228MF10230
02 1229MF10034
03 1229MF10053
04 1229MF10073
05 1301MF10027
06 1304MF10104
07 19Blank
01 1WC-0014
02 1WC-0015
03 1WC-0072
04 1WC-0127
05 1WC-0170
06 20Blank
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22094
Submission : 2008-10-17
Status : Active
Type : II
NDC Package Code : 46014-1126
Start Marketing Date : 2017-10-12
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 : 39321
Submission : 2023-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37017
Submission : 2022-03-30
Status : Active
Type : II
Registration Number : 229MF10053
Registrant's Address : 2nd Floor, Admin Block 27, Vandalooor kelambakkam Road, Keelakottaiyur Village, Melakottaiyur PO, Chennai 600 127 Tamilna
Initial Date of Registration : 2017-02-28
Latest Date of Registration : --
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37018
Submission : 2022-03-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-14
Pay. Date : 2015-12-08
DMF Number : 23254
Submission : 2009-11-05
Status : Active
Type : II
Date of Issue : 2024-04-23
Valid Till : 2027-04-22
Written Confirmation Number : WC-0170
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-14
Pay. Date : 2015-09-30
DMF Number : 22050
Submission : 2008-10-02
Status : Active
Type : II
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0014
Address of the Firm :
NDC Package Code : 63850-2761
Start Marketing Date : 2005-11-23
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 : 37058
Submission : 2023-03-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28008
Submission : 2014-06-05
Status : Inactive
Type : II
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