Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1LGM Pharma
03 1Dr. Reddy's Laboratories
04 1Alembic Pharmaceuticals Limited
05 1Aurobindo Pharma Limited
06 1Glenmark Life Sciences
07 1Glenmark Pharmaceuticals
08 1Guangzhou Tosun Pharmaceutical
09 1Jin Dun Medical
10 1Kukjeon Pharmaceutical
11 2MSN Laboratories
12 1Phalanx Labs
13 1Smilax Laboratories Limited
14 1UBE Industries
15 1Unichem Laboratories Limited
16 2Viatris
01 2China
02 10India
03 1Japan
04 1South Korea
05 1Spain
06 3U.S.A
01 2Inactive
02 16Blank
01 18Blank
01 18Blank
01 1WC-0021
02 1WC-0021n
03 1WC-0057n
04 1WC-0067
05 1WC-0082
06 1WC-0157
07 12Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15058
Submission : 2000-09-22
Status : Inactive
Type : II
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm :
NDC Package Code : 53747-048
Start Marketing Date : 2015-01-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2015-12-02
Registration Number : Su4579-7-ND
Manufacturer Name : Alembic Pharmaceuticals Limited
Manufacturer Address : Plot No. 842-843, TAL-Padra, City : Karakhadi - 391 450, Dist : Vadodara, Gujarat State, India
Date of Issue : 2019-10-11
Valid Till : 2022-07-02
Written Confirmation Number : WC-0157
Address of the Firm :
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