Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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02 1Shandong Chenghui Shuangda Pharmaceutical
03 1Shanghai Minbiotech
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01 1WC-0349
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01 1Su173-66-ND
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01 150923-0117
02 154893-0087
03 168554-0150
04 169988-0047
05 172804-0002
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Lee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-07-19
Pay. Date : 2019-05-28
DMF Number : 33637
Submission : 2019-02-28
Status : Active
Type : II
Date of Issue : 2025-09-19
Valid Till : 2028-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0087
Start Marketing Date : 2019-02-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2025-10-13
Registration Number : Su173-66-ND
Manufacturer Name : MSN Laboratories Private Limited
Manufacturer Address : (Unit-ll) Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal), Sangareddy District, Telangana, Pincode: 502 300, India

GDUFA
DMF Review : Reviewed
Rev. Date : 2025-09-03
Pay. Date : 2025-08-22
DMF Number : 34128
Submission : 2019-12-16
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2022-06-28
Pay. Date : 2022-03-15
DMF Number : 36908
Submission : 2022-03-25
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40093
Submission : 2024-06-13
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33869
Submission : 2019-06-12
Status : Inactive
Type : II

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We have 23 companies offering Alectinib HCl
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