ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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01 1ChemWerth Inc
02 1LGM Pharma
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04 1HRV Pharma
05 1Synbias Pharma AG
06 1AMPAC Fine Chemicals
07 1Agno Pharma
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09 2Apothecon Pharmaceuticals
10 1Aspen Bio
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12 1Bristol Myers Squibb
13 1ChemGenix Laboratories Pvt Ltd
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17 1Jiangsu Hengrui Medicine
18 1MSN Laboratories
19 1MilverPharma Pvt Ltd
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01 1WC-0120
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01 120210426-210-J-954
02 120250822-210-J-2000
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01 114593-823
02 150137-0686
03 150683-0017
04 154893-0055
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10290
Submission : 1993-06-14
Status : Active
Type : II
NDC Package Code : 50137-0686
Start Marketing Date : 2014-06-13
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/1)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-06-15
Pay. Date : 2017-05-24
DMF Number : 31156
Submission : 2016-12-30
Status : Active
Type : II
Certificate Number : CEP 2017-231 - Rev 04
Issue Date : 2024-09-03
Type : Chemical
Substance Number : 1187
Status : Valid
Date of Issue : 2025-09-19
Valid Till : 2028-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0055
Start Marketing Date : 2016-12-30
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-02
Pay. Date : 2021-09-23
DMF Number : 32922
Submission : 2018-07-31
Status : Active
Type : II
Certificate Number : R0-CEP 2021-212 - Rev 00
Issue Date : 2023-08-07
Type : Chemical
Substance Number : 1187
Status : Valid

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34547
Submission : 2020-03-03
Status : Active
Type : II
NDC Package Code : 70225-1107
Start Marketing Date : 2020-02-19
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 : 38686
Submission : 2023-12-31
Status : Active
Type : II
Certificate Number : CEP 2023-259 - Rev 00
Issue Date : 2025-07-16
Type : Chemical
Substance Number : 1187
Status : Valid
NDC Package Code : 87072-0002
Start Marketing Date : 2025-09-01
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 : 2038
Submission : 1973-01-10
Status : Inactive
Type : II

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PharmaCompass offers a list of Carmustine 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 Carmustine manufacturer or Carmustine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Carmustine manufacturer or Carmustine supplier.
A BCNU manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BCNU, including repackagers and relabelers. The FDA regulates BCNU manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BCNU 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 BCNU manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A BCNU supplier is an individual or a company that provides BCNU active pharmaceutical ingredient (API) or BCNU finished formulations upon request. The BCNU suppliers may include BCNU API manufacturers, exporters, distributors and traders.
click here to find a list of BCNU suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 27 companies offering BCNU
Get in contact with the supplier of your choice: