Inke S.A: APIs manufacturing plant.
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01 1Inke S.A
02 1LGM Pharma
03 1Aspen API
04 1Acura Labs
05 1Alembic Pharmaceuticals Limited
06 1CHEMO
07 1CHEMO IBERICA SA
08 1Globofarm International
09 1Haoyuan Chemexpress Co.Ltd
10 1Hisamitsu Pharmaceutical Co., Inc.
11 1Lupin Ltd
12 2MSN Laboratories
13 1Medichem S.A
14 1Megafine Pharma (P) Limited
15 1Olon S.p.A
16 1Shouyuan Chemical
17 1Sigmapharm Laboratories, LLC
18 1Signa S.A. de C.V.
19 1Sun Pharmaceutical Industries Limited
20 1Viatris
21 1Zhejiang Ausun Pharmaceutical
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01 3China
02 8India
03 1Italy
04 1Japan
05 1Mexico
06 1Netherlands
07 4Spain
08 3U.S.A
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01 11Active
02 3Inactive
03 8Blank
01 22Blank
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01 1227MF10107
02 21Blank
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01 1WC-0082
02 1WC-0087-(Annexure-1)
03 1WC-0281A3
04 1WC-0281new2
05 18Blank
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01 22Blank
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01 117337-0309
02 150379-0004
03 150379-0009
04 153296-0104
05 160870-0468
06 165015-817
07 16Blank
01 22Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34868
Submission : 2020-06-10
Status : Active
Type : II
Registration Number : 227MF10107
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2015-04-09
Latest Date of Registration :
NDC Package Code : 60870-0468
Start Marketing Date : 2015-03-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-22
Pay. Date : 2013-08-13
DMF Number : 27300
Submission : 2013-08-08
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-12-20
Pay. Date : 2024-12-13
DMF Number : 26104
Submission : 2012-05-30
Status : Active
Type : II
NDC Package Code : 17337-0309
Start Marketing Date : 2012-04-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-14
Pay. Date : 2013-05-13
DMF Number : 27086
Submission : 2013-05-17
Status : Active
Type : II
NDC Package Code : 65015-817
Start Marketing Date : 2015-01-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-09
Pay. Date : 2013-05-24
DMF Number : 26785
Submission : 2013-03-08
Status : Active
Type : II
Date of Issue : 2020-04-15
Valid Till : 2023-05-19
Written Confirmation Number : WC-0281new2
Address of the Firm :
NDC Package Code : 50379-0009
Start Marketing Date : 2012-07-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-01
Pay. Date : 2013-06-25
DMF Number : 27185
Submission : 2013-07-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27290
Submission : 2013-07-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27316
Submission : 2013-07-26
Status : Inactive
Type : II
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