ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
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01 2ASolution Pharmaceuticals
02 2Mankind Pharma
03 2Fermion Oy
04 1Nuray Chemicals Private Limited
05 1Rochem International Inc
06 1Chynops Pharma
07 1HRV Global Life Sciences
08 1Olpha
09 1Neuland Laboratories
10 1TAPI Technology & API Services
11 1Zeal MediPharma
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27 1Roche Diagnostics GmbH
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01 3China
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11 5U.S.A
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01 26Active
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02 12Valid
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01 53Blank
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01 1WC-0037
02 1WC-0170
03 1WC-0231A4
04 1WC-0407a4
05 1WC-0416
06 1WC-0473
07 1WC-476
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ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38079
Submission : 2023-05-10
Status : Active
Type : II
Date of Issue : 2024-01-23
Valid Till : 2026-06-17
Written Confirmation Number : WC-476
Address of the Firm :
NDC Package Code : 84668-015
Start Marketing Date : 2024-08-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-26
Pay. Date : 2019-03-05
DMF Number : 33351
Submission : 2018-12-28
Status : Active
Type : II
Certificate Number : CEP 2019-092 - Rev 02
Issue Date : 2023-10-12
Type : Chemical
Substance Number : 101
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-01-15
Pay. Date : 2019-11-05
DMF Number : 33838
Submission : 2019-10-15
Status : Active
Type : II
Certificate Number : R0-CEP 2019-206 - Rev 02
Issue Date : 2023-03-16
Type : Chemical
Substance Number : 101
Status : Valid
Available Reg Filing : ASMF |
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-038
Start Marketing Date : 2020-08-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
ASolution Pharmaceuticals: Your Partner for cGMP Development & Manufacturing Services – Supplying APIs, FDFs, and Specialty Molecules.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38080
Submission : 2023-05-10
Status : Active
Type : II
NDC Package Code : 84668-015
Start Marketing Date : 2024-08-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-26
Pay. Date : 2019-03-05
DMF Number : 33523
Submission : 2019-02-23
Status : Active
Type : II
Certificate Number : R0-CEP 2021-371 - Rev 00
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 101
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-12-27
Pay. Date : 2019-12-02
DMF Number : 33839
Submission : 2019-11-20
Status : Active
Type : II
Available Reg Filing : ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-01-07
Pay. Date : 2021-10-29
DMF Number : 36390
Submission : 2021-10-26
Status : Active
Type : II
Certificate Number : R0-CEP 2022-051 - Rev 00
Issue Date : 2023-07-11
Type : Chemical
Substance Number : 101
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-01-07
Pay. Date : 2021-11-05
DMF Number : 36391
Submission : 2021-11-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23500
Submission : 2010-02-16
Status : Active
Type : II
Certificate Number : R1-CEP 2011-108 - Rev 01
Issue Date : 2020-09-23
Type : Chemical
Substance Number : 101
Status : Suspended by Holder
Date of Issue : 2024-04-23
Valid Till : 2027-04-22
Written Confirmation Number : WC-0170
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-31
Pay. Date : 2013-07-22
DMF Number : 23501
Submission : 2010-02-16
Status : Active
Type : II
Certificate Number : R1-CEP 2014-226 - Rev 00
Issue Date : 2021-10-06
Type : Chemical
Substance Number : 101
Status : Suspended by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23570
Submission : 2010-03-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-07
Pay. Date : 2014-03-25
DMF Number : 26176
Submission : 2012-06-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-10-21
Pay. Date : 2016-08-24
DMF Number : 30285
Submission : 2016-05-19
Status : Active
Type : II
Certificate Number : R1-CEP 2016-212 - Rev 00
Issue Date : 2023-06-14
Type : Chemical
Substance Number : 101
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-20
Pay. Date : 2016-09-20
DMF Number : 30755
Submission : 2016-08-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24645
Submission : 2011-02-15
Status : Active
Type : II
Certificate Number : R0-CEP 2011-240 - Rev 01
Issue Date : 2015-01-15
Type : Chemical
Substance Number : 101
Status : Withdrawn by EDQM F...
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-09-08
Pay. Date : 2022-07-27
DMF Number : 33877
Submission : 2019-05-31
Status : Active
Type : II
Certificate Number : R0-CEP 2022-074 - Rev 00
Issue Date : 2022-12-12
Type : Chemical
Substance Number : 101
Status : Valid
Date of Issue : 2020-10-20
Valid Till : 2023-06-28
Written Confirmation Number : WC-0407a4
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34179
Submission : 2019-09-30
Status : Active
Type : II
Certificate Number : CEP 2019-262 - Rev 01
Issue Date : 2024-05-02
Type : Chemical
Substance Number : 101
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-02-05
Pay. Date : 2024-12-31
DMF Number : 34631
Submission : 2020-03-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4303
Submission : 1981-09-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 454
Submission : 1961-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1733
Submission : 1971-06-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7979
Submission : 1989-03-17
Status : Inactive
Type : II
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PharmaCompass offers a list of Nitrofurantoin 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 Nitrofurantoin manufacturer or Nitrofurantoin supplier for your needs.
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A Nitrofurantoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitrofurantoin, including repackagers and relabelers. The FDA regulates Nitrofurantoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitrofurantoin 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 Nitrofurantoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nitrofurantoin supplier is an individual or a company that provides Nitrofurantoin active pharmaceutical ingredient (API) or Nitrofurantoin finished formulations upon request. The Nitrofurantoin suppliers may include Nitrofurantoin API manufacturers, exporters, distributors and traders.
click here to find a list of Nitrofurantoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 35 companies offering Nitrofurantoin
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