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

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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-22
Pay. Date : 2014-09-04
DMF Number : 28230
Submission : 2014-09-11
Status : Active
Type : II
Certificate Number : R0-CEP 2020-350 - Rev 00
Issue Date : 2023-02-16
Type : Chemical
Substance Number : 1798
Status : Valid
Date of Issue : 2025-08-08
Valid Till : 2028-08-07
Written Confirmation Number : WC-0424
Address of the Firm :
NDC Package Code : 42413-0108
Start Marketing Date : 2014-07-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41847
Submission : 2025-04-30
Status : Active
Type : II
NDC Package Code : 70600-068
Start Marketing Date : 2025-04-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21400
Submission : 2008-03-04
Status : Active
Type : II
Certificate Number : R1-CEP 2009-213 - Rev 00
Issue Date : 2016-12-05
Type : Chemical
Substance Number : 1798
Status : Valid
| Available Reg Filing : ASMF |

GDUFA
DMF Review : Reviewed
Rev. Date : 2023-02-17
Pay. Date : 2023-02-15
DMF Number : 22673
Submission : 2009-03-30
Status : Active
Type : II
Certificate Number : CEP 2010-040 - Rev 06
Issue Date : 2026-05-22
Type : Chemical
Substance Number : 1798
Status : Valid
Date of Issue : 2022-07-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm :
NDC Package Code : 66039-864
Start Marketing Date : 2009-03-20
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23929
Submission : 2010-06-25
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22718
Submission : 2009-04-07
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23413
Submission : 2009-12-29
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21171
Submission : 2007-10-10
Status : Inactive
Type : II
Certificate Number : R1-CEP 2007-272 - Rev 00
Issue Date : 2016-02-15
Type : Chemical
Substance Number : 1798
Status : Valid

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PharmaCompass offers a list of Trospium Chloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Trospium Chloride manufacturer or Trospium Chloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Trospium Chloride manufacturer or Trospium Chloride supplier.
A Trospi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trospi, including repackagers and relabelers. The FDA regulates Trospi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trospi 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 Trospi manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Trospi supplier is an individual or a company that provides Trospi active pharmaceutical ingredient (API) or Trospi finished formulations upon request. The Trospi suppliers may include Trospi API manufacturers, exporters, distributors and traders.
click here to find a list of Trospi suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 25 companies offering Trospi
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