Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.
01 1Tofigh Daru
02 1Dr. Reddy's Laboratories
03 1LGM Pharma
04 1HRV Global Life Sciences
05 1Omgene Life Sciences Pvt. Ltd
06 1TAPI Technology & API Services
07 1Alembic Pharmaceuticals Limited
08 1AmbioPharm
09 1Auro Peptides Limited
10 1Aurobindo Pharma Limited
11 1Biocon
12 1Cipla
13 1CordenPharma
14 1GLAND PHARMA LIMITED
15 1Hybio Pharmaceutical
16 1KinBio
17 1Natco Pharma
18 1Piramal Pharma Solutions
19 1Sajjala Bio Labs
20 1Tecoland Corporation
01 1China
02 1Germany
03 11India
04 1Iran
05 2Israel
06 4U.S.A
01 6Active
02 1Inactive
03 13Blank
01 20Blank
01 20Blank
01 1WC-0014
02 1WC-0038n
03 1WC-0067
04 1WC-0427A3-4
05 16Blank
Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-05
Pay. Date : 2013-12-31
DMF Number : 25855
Submission : 2012-03-24
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 55111-945
Start Marketing Date : 2012-03-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7609
Submission : 1988-08-02
Status : Inactive
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 : 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 : 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 : 2016-08-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33092
Submission : 2018-09-12
Status : Active
Type : II
Date of Issue : 2022-08-04
Valid Till : 2025-03-04
Written Confirmation Number : WC-0427A3-4
Address of the Firm :
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
Date of Issue : 2022-07-06
Valid Till : 2025-08-04
Written Confirmation Number : WC-0038n
Address of the Firm :
NDC Package Code : 65727-038
Start Marketing Date : 2023-07-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (2kg/2kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0014
Address of the Firm :
NDC Package Code : 53104-7715
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59651-517
Start Marketing Date : 2020-12-19
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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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