LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Omgene Life Sciences Pvt. Ltd
03 1Actavis Inc
04 1Alcami
05 1Anvitha Lifecare
06 1Apotex Pharmachem
07 1CHEMO
08 1Edmond Pharma
09 1Emcure Pharmaceuticals
10 1Enaltec Labs Private Limited
11 1Hetero Drugs
12 1Industriale Chimica
13 1Ipca Laboratories
14 1Laboratori Alchemia Srl
15 1Mankind Pharma
16 1Nycomed Austria GmbH
17 1Ohara Pharmaceutical
18 1Optimus Pharma
19 1Par Pharmaceutical
20 1Recipharm AB
21 1Refarmed Chemicals
22 1Tianjin Weijie Pharmaceutical Co., Ltd.
23 2Zydus Lifesciences
01 1Austria
02 1Canada
03 1China
04 11India
05 1Ireland
06 2Italy
07 1Japan
08 1Spain
09 1Sweden
10 1Switzerland
11 3U.S.A
01 12Active
02 2Inactive
03 10Blank
01 24Blank
01 1217MF10582
02 1217MF11229
03 1221MF10211
04 21Blank
01 1WC-0084
02 1WC-0091
03 1WC-0226
04 1WC-0424
05 20Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-08
Pay. Date : 2021-09-16
DMF Number : 36272
Submission : 2021-09-21
Status : Active
Type : II
NDC Package Code : 59285-043
Start Marketing Date : 2021-12-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-01
Pay. Date : 2014-04-29
DMF Number : 28211
Submission : 2014-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16481
Submission : 2003-03-24
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-29
Pay. Date : 2014-05-12
DMF Number : 16006
Submission : 2002-06-13
Status : Active
Type : II
NDC Package Code : 63190-0080
Start Marketing Date : 2004-11-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-16
Pay. Date : 2013-09-25
DMF Number : 27464
Submission : 2013-09-18
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0091
Address of the Firm :
NDC Package Code : 57451-1204
Start Marketing Date : 2013-07-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-11
Pay. Date : 2018-10-04
DMF Number : 16017
Submission : 2002-06-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30216
Submission : 2016-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6315
Submission : 1986-03-10
Status : Inactive
Type : II
A Midodrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Midodrine, including repackagers and relabelers. The FDA regulates Midodrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Midodrine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Midodrine supplier is an individual or a company that provides Midodrine active pharmaceutical ingredient (API) or Midodrine finished formulations upon request. The Midodrine suppliers may include Midodrine API manufacturers, exporters, distributors and traders.
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