Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1LGM Pharma
03 1Aspen API
04 1Dr. Reddy's Laboratories
05 1Medichem S.A
06 1Acura Labs
07 1Alembic Pharmaceuticals Limited
08 1CHEMO
09 1CHEMO IBERICA SA
10 1Globofarm International
11 1Haoyuan Chemexpress Co.Ltd
12 1Hisamitsu Pharmaceutical Co., Inc.
13 1Lupin Ltd
14 2MSN Laboratories
15 1Megafine Pharma (P) Limited
16 1Olon S.p.A
17 1Shouyuan Chemical
18 1Sigmapharm Laboratories, LLC
19 1Signa S.A. de C.V.
20 1Sun Pharmaceutical Industries Limited
21 1Viatris
22 1Zhejiang Ausun Pharmaceutical
01 3China
02 9India
03 1Italy
04 1Japan
05 1Mexico
06 1Netherlands
07 4Spain
08 3U.S.A
01 11Active
02 3Inactive
03 9Blank
01 23Blank
01 1227MF10107
02 22Blank
01 1WC-0067
02 1WC-0082
03 1WC-0087-(Annexure-1)
04 1WC-0281A3
05 1WC-0281new2
06 18Blank
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 : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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 :
NDC Package Code : 55111-937
Start Marketing Date : 2013-01-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-01
Pay. Date : 2013-05-01
DMF Number : 26923
Submission : 2013-05-16
Status : Active
Type : II
NDC Package Code : 53296-0104
Start Marketing Date : 2011-04-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
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 : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
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 : 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 : 27316
Submission : 2013-07-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27290
Submission : 2013-07-08
Status : Inactive
Type : II
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