LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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01 1LGM Pharma
02 1HRV Pharma
03 1Omgene Life Sciences Pvt. Ltd
04 1Sigma-Aldrich Corporation
05 1Alembic Pharmaceuticals Limited
06 1AmbioPharm
07 1Auro Peptides Limited
08 1Aurobindo Pharma Limited
09 1Biocon
10 1Cipla
11 1CordenPharma
12 1GLAND PHARMA LIMITED
13 1Hybio Pharmaceutical
14 1Jade Nutripharma
15 1KinBio
16 1Natco Pharma
17 1Piramal Pharma Solutions
18 1Sajjala Bio Labs
19 1ScinoPharm Taiwan Ltd
20 1Synthon Pharmaceuticals
21 1Blank
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01 2China
02 1Germany
03 10India
04 1Israel
05 1Netherlands
06 1Taiwan
07 4U.S.A
08 1Blank
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01 5Active
02 16Blank
01 21Blank
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01 21Blank
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01 1WC-0038
02 1WC-014
03 1WC-0427
04 18Blank
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01 21Blank
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01 10441-3642
02 114403-0008
03 124795-0063
04 141524-0004
05 155111-945
06 159651-517
07 165129-1181
08 165727-038
09 13Blank
01 21Blank
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.
Sigma-Aldrich empowers scientific discovery with top-quality solutions to accelerate research, innovation, and better health worldwide.
NDC Package Code : 0441-3642
Start Marketing Date : 2015-04-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-05
Pay. Date : 2014-06-09
DMF Number : 26489
Submission : 2012-09-27
Status : Active
Type : II
NDC Package Code : 41524-0004
Start Marketing Date : 2012-09-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-08
Pay. Date : 2020-12-24
DMF Number : 35493
Submission : 2020-12-25
Status : Active
Type : II


GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-05
Pay. Date : 2013-11-22
DMF Number : 27723
Submission : 2013-12-12
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-07
Pay. Date : 2018-02-09
DMF Number : 28989
Submission : 2014-12-25
Status : Active
Type : II
NDC Package Code : 14403-0008
Start Marketing Date : 2025-01-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

Date of Issue : 2025-12-24
Valid Till : 2028-08-04
Written Confirmation Number : WC-0038
Address of the Firm :
NDC Package Code : 65727-038
Start Marketing Date : 2023-07-05
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (2kg/2kg)
Marketing Category : BULK INGREDIENT

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A Copaxone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Copaxone, including repackagers and relabelers. The FDA regulates Copaxone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Copaxone 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 Copaxone supplier is an individual or a company that provides Copaxone active pharmaceutical ingredient (API) or Copaxone finished formulations upon request. The Copaxone suppliers may include Copaxone API manufacturers, exporters, distributors and traders.
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