Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
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01 1FARMAK, a.s
02 1Octavius Pharma Pvt. Ltd
03 2Sanofi
04 1LGM Pharma
05 1HRV Global Life Sciences
06 1Bal Pharma
07 1Almelo
08 1Anwita Drugs & Chemicals Pvt Ltd
09 1Apotex Pharmachem
10 1Aspen Biopharma Labs
11 1Aurobindo Pharma Limited
12 1Cipla
13 1Glenmark Life Sciences
14 1Glenmark Pharmaceuticals
15 1Globalchem
16 1Guangzhou Tosun Pharmaceutical
17 1H. Lundbeck AS
18 1Hetero Drugs
19 1Lunan Pharmaceutical
20 1MSN Laboratories
21 1Standard Chem. & Pharm. Co., Ltd
22 1Titan Laboratories
23 1Torrent Pharmaceuticals Limited
24 1Unichem Laboratories Limited
25 1Unipex
26 1Wockhardt
27 1Zydus Lifesciences
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01 1Canada
02 3China
03 1Czech Republic
04 1Denmark
05 3France
06 18India
07 1U.S.A
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01 9Active
02 6Inactive
03 13Blank
01 4Valid
02 3Withdrawn by Holder
03 21Blank
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01 28Blank
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01 1WC-0017
02 1WC-0021n
03 1WC-0040
04 1WC-0062
05 24Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Certificate Number : R1-CEP 2003-098 - Rev 02
Issue Date : 2021-08-18
Type : Chemical
Substance Number : 1287
Status : Valid
NDC Package Code : 63278-0500
Start Marketing Date : 2004-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ankuk Pharmaceutical Co., Ltd.
Registration Date : 2020-07-02
Registration Number : 20200115-209-J-260(1)
Manufacturer Name : Farmak, as
Manufacturer Address : Na vlcinci 16/3, Klasterni Hradisko, 779 00 Olomouc, Czech Republic
Available Reg Filing : ASMF |
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11976
Submission : 1996-05-14
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20888
Submission : 2007-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23603
Submission : 2010-03-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20867
Submission : 2007-09-17
Status : Active
Type : II
Certificate Number : CEP 2006-208 - Rev 06
Issue Date : 2024-01-31
Type : Chemical
Substance Number : 1287
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0003
Start Marketing Date : 2010-03-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20439
Submission : 2007-04-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20577
Submission : 2007-06-07
Status : Active
Type : II
Date of Issue : 2022-07-04
Valid Till : 2025-07-03
Written Confirmation Number : WC-0040
Address of the Firm :
NDC Package Code : 65977-0023
Start Marketing Date : 2003-12-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19675
Submission : 2006-08-10
Status : Active
Type : II
NDC Package Code : 66039-826
Start Marketing Date : 2006-08-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20595
Submission : 2007-06-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22638
Submission : 2009-03-30
Status : Active
Type : II
Certificate Number : CEP 2008-294 - Rev 01
Issue Date : 2024-11-07
Type : Chemical
Substance Number : 1287
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-21
Written Confirmation Number : WC-0062
Address of the Firm :
NDC Package Code : 53747-019
Start Marketing Date : 2009-03-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2019-10-10
Registration Number : 20191010-209-J-253
Manufacturer Name : Unichem Laboratories Limited
Manufacturer Address : Plot No. 197, Sector-1, Pithampur, Dist. Dhar (M.P.), India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20307
Submission : 2007-02-24
Status : Active
Type : II
Certificate Number : CEP 2007-080 - Rev 03
Issue Date : 2023-11-16
Type : Chemical
Substance Number : 1287
Status : Valid
Date of Issue : 2022-06-06
Valid Till : 2025-06-10
Written Confirmation Number : WC-0017
Address of the Firm :
NDC Package Code : 65862-206
Start Marketing Date : 2023-12-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2019-06-25
Registration Number : 20190625-209-J-376
Manufacturer Name : Apitoria Pharma Private Limited Unit-II
Manufacturer Address : Survey No. 10 & 13, IDA, Kazipally, Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana State, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20540
Submission : 2007-05-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19786
Submission : 2006-12-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20350
Submission : 2007-03-13
Status : Inactive
Type : II
Certificate Number : R0-CEP 2008-309 - Rev 00
Issue Date : 2010-05-17
Type : Chemical
Substance Number : 1287
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19180
Submission : 2006-08-07
Status : Inactive
Type : II
Certificate Number : R1-CEP 2007-031 - Rev 00
Issue Date : 2014-11-10
Type : Chemical
Substance Number : 1287
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20379
Submission : 2007-03-28
Status : Inactive
Type : II
Certificate Number : R1-CEP 2007-282 - Rev 01
Issue Date : 2015-06-29
Type : Chemical
Substance Number : 1287
Status : Withdrawn by Holder
A Sanofi brand of alfuzosin hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sanofi brand of alfuzosin hydrochloride, including repackagers and relabelers. The FDA regulates Sanofi brand of alfuzosin hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sanofi brand of alfuzosin hydrochloride 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 Sanofi brand of alfuzosin hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sanofi brand of alfuzosin hydrochloride supplier is an individual or a company that provides Sanofi brand of alfuzosin hydrochloride active pharmaceutical ingredient (API) or Sanofi brand of alfuzosin hydrochloride finished formulations upon request. The Sanofi brand of alfuzosin hydrochloride suppliers may include Sanofi brand of alfuzosin hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sanofi brand of alfuzosin hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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