Enaltec Labs –Delivering complex APIs with precision, innovation, and global compliance.

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GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-17
Pay. Date : 2016-09-26
DMF Number : 30806
Submission : 2016-09-27
Status : Active
Type : II
Date of Issue : 2025-08-08
Valid Till : 2028-08-07
Written Confirmation Number : WC-0424
Address of the Firm :
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.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-01-16
Pay. Date : 2025-01-06
DMF Number : 40408
Submission : 2024-11-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39885
Submission : 2024-08-23
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 : 2021-11-08
Pay. Date : 2021-09-16
DMF Number : 36272
Submission : 2021-09-21
Status : Active
Type : II
Date of Issue : 2025-09-12
Valid Till : 2028-07-02
Written Confirmation Number : WC-0182
Address of the Firm :
NDC Package Code : 59285-043
Start Marketing Date : 2021-12-30
End Marketing Date : 2026-12-31
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

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PharmaCompass offers a list of Midodrine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Midodrine manufacturer or Midodrine supplier for your needs.
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PharmaCompass also assists you with knowing the Midodrine API Price utilized in the formulation of products. Midodrine API Price is not always fixed or binding as the Midodrine Price is obtained through a variety of data sources. The Midodrine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
click here to find a list of Midodrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
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.
click here to find a list of Midodrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 26 companies offering Midodrine
Get in contact with the supplier of your choice: