Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
01 2Alchem International Private Ltd
02 1Sanofi
03 1LGM Pharma
04 1DKSH
05 1Jai Radhe Sales
06 1Phytex Australia
07 1Alkaloids Corporation
08 1Chemical Resources
09 1Ennature Biopharma
10 1HONOUR LAB LTD
11 1Hindustan Herbals Limited
12 3Indena
13 1India Glycols
14 1Inga Pharmaceuticals
15 1Jin Dun Medical
16 1Johannes Burger Bau
17 1Par Pharmaceutical
18 1Remedy Labs
19 1Sanmar Speciality Chemicals Limited IN 600 086 Chennai
20 1Sarv Biolabs Pvt Ltd
21 2Solara Active Pharma Sciences
22 1Varion Lifesciences
23 1Vital Laboratories Private Limited
24 1elm-plastic GmbH
25 1Blank
01 1Australia
02 1China
03 1France
04 2Germany
05 17India
06 3Italy
07 1Switzerland
08 2U.S.A
09 1Blank
01 10Active
02 5Inactive
03 14Blank
01 7Valid
02 2Withdrawn by EDQM Failure to CEP procedure
03 20Blank
01 1218MF10226
02 28Blank
01 1WC-0006
02 1WC-0192
03 1WC-0294
04 1WC-0294A3
05 1WC-0300
06 1WC-0362
07 1WC-0450
08 22Blank
Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22564
Submission : 2009-02-18
Status : Active
Type : II
Certificate Number : CEP 2019-146 - Rev 01
Issue Date : 2024-02-16
Type : Chemical
Substance Number : 758
Status : Valid
Date of Issue : 2022-05-27
Valid Till : 2025-05-26
Written Confirmation Number : WC-0006
Address of the Firm :
NDC Package Code : 55742-127
Start Marketing Date : 2016-12-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : CN |
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 : 5163
Submission : 1983-12-01
Status : Inactive
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Experts in producing high-quality APIs from natural sources, specializing in advanced extraction and isolation techniques.
Alchem offers Phytochemical APIs for Pharmaceuticals, Cosmetics and Nutraceuticals// FDA-inspected and EU-GMP certified.
NDC Package Code : 55742-127
Start Marketing Date : 2016-12-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : CN |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32072
Submission : 2017-09-20
Status : Active
Type : II
Date of Issue : 2022-12-30
Valid Till : 2025-08-05
Written Confirmation Number : WC-0450
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-19
Pay. Date : 2016-02-23
DMF Number : 29940
Submission : 2015-10-21
Status : Active
Type : II
Certificate Number : CEP 2021-160 - Rev 01
Issue Date : 2024-05-15
Type : Chemical
Substance Number : 758
Status : Valid
Date of Issue : 2021-08-06
Valid Till : 2024-03-04
Written Confirmation Number : WC-0294
Address of the Firm :
NDC Package Code : 72643-009
Start Marketing Date : 2017-11-14
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 : 35640
Submission : 2021-03-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-07
Pay. Date : 2013-02-25
DMF Number : 10088
Submission : 1993-02-10
Status : Active
Type : II
Certificate Number : CEP 2024-164 - Rev 00
Issue Date : 2024-08-16
Type : Chemical
Substance Number : 758
Status : Valid
Registration Number : 218MF10226
Registrant's Address : Viale Ortles 12 Milan Italy
Initial Date of Registration : 2006-02-16
Latest Date of Registration :
NDC Package Code : 17359-5000
Start Marketing Date : 1993-03-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31471
Submission : 2017-02-03
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-02-18
Pay. Date : 2015-05-26
DMF Number : 29401
Submission : 2015-06-05
Status : Active
Type : II
Date of Issue : 2019-07-26
Valid Till : 2022-05-05
Written Confirmation Number : WC-0362
Address of the Firm :
NDC Package Code : 69037-0011
Start Marketing Date : 2009-07-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-05
Pay. Date : 2013-12-05
DMF Number : 27722
Submission : 2013-12-06
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-07-24
Pay. Date : 2020-07-16
DMF Number : 24155
Submission : 2010-09-09
Status : Active
Type : II
Date of Issue : 2020-01-29
Valid Till : 2022-07-02
Written Confirmation Number : WC-0192
Address of the Firm :
NDC Package Code : 68404-0001
Start Marketing Date : 2017-11-16
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 : 20149
Submission : 2007-01-12
Status : Active
Type : II
Certificate Number : R1-CEP 2002-062 - Rev 01
Issue Date : 2009-11-18
Type : Chemical
Substance Number : 758
Status : Withdrawn by EDQM F...
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24726
Submission : 2011-01-18
Status : Inactive
Type : II
Certificate Number : R0-CEP 2011-016 - Rev 00
Issue Date : 2012-01-19
Type : Chemical
Substance Number : 758
Status : Withdrawn by EDQM F...
Date of Issue : 2024-05-20
Valid Till : 2027-01-08
Written Confirmation Number : WC-0300
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22115
Submission : 2008-10-29
Status : Inactive
Type : II
Certificate Number : R0-CEP 2021-118 - Rev 00
Issue Date : 2021-08-13
Type : Chemical
Substance Number : 758
Status : Valid
NDC Package Code : 17359-5000
Start Marketing Date : 1993-03-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2113
Submission : 1973-06-13
Status : Inactive
Type : II
Date of Issue : 2020-08-07
Valid Till : 2021-03-04
Written Confirmation Number : WC-0294A3
Address of the Firm :
NDC Package Code : 72643-009
Start Marketing Date : 2017-11-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2004-182 - Rev 04
Issue Date : 2024-11-13
Type : Chemical
Substance Number : 758
Status : Valid
NDC Package Code : 17359-5000
Start Marketing Date : 1993-03-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Certificate Number : R0-CEP 2020-251 - Rev 00
Issue Date : 2022-07-25
Type : Chemical
Substance Number : 758
Status : Valid
Certificate Number : R0-CEP 2019-056 - Rev 01
Issue Date : 2023-07-13
Type : Chemical
Substance Number : 758
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11771
Submission : 1995-12-12
Status : Inactive
Type : II
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A Colchicine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Colchicine, including repackagers and relabelers. The FDA regulates Colchicine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Colchicine 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 Colchicine supplier is an individual or a company that provides Colchicine active pharmaceutical ingredient (API) or Colchicine finished formulations upon request. The Colchicine suppliers may include Colchicine API manufacturers, exporters, distributors and traders.
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