Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.

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01 1Gentec Pharmaceutical Group
02 1Enaltec Labs
03 1CARBOGEN AMCIS AG
04 1Catalent Pharma Solutions
05 1DISHMAN NETHERLANDS B.V.
06 1Dishman Carbogen Amcis
07 1DongWha Pharm
08 1Formosa Laboratories
09 1Hanways Chempharm
10 1Jiangxi Tianxin Pharmaceutical
11 2Lukasiewicz Industrial Chemistry Institute
12 1SOLVAY -Technology Solutions
13 1Zhejiang Ausun Pharmaceutical
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01 3China
02 1Germany
03 2India
04 1Netherlands
05 2Poland
06 1South Korea
07 1Spain
08 1Switzerland
09 1Taiwan
10 1U.S.A
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01 2Active
02 2Inactive
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01 3Valid
02 1Withdrawn by Holder
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01 14Blank
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01 145408-002
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Gentec Pharmaceutical Group is focused on manufacturing & developing APIs/HPAPIs, Advanced Intermediates & Fine Chemicals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-28
Pay. Date : 2016-07-08
DMF Number : 21963
Submission : 2008-09-05
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33640
Submission : 2019-05-03
Status : Active
Type : II
Certificate Number : CEP 2019-163 - Rev 03
Issue Date : 2025-07-31
Type : Chemical
Substance Number : 1295
Status : Valid

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15564
Submission : 2001-08-02
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12386
Submission : 1997-02-27
Status : Inactive
Type : II


Certificate Number : CEP 1998-059 - Rev 09
Issue Date : 2024-12-02
Type : Chemical and TSE
Substance Number : 1295
Status : Valid
NDC Package Code : 45408-002
Start Marketing Date : 2012-08-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

Certificate Number : R0-CEP 2022-335 - Rev 00
Issue Date : 2022-11-29
Type : Chemical
Substance Number : 1295
Status : Valid

Certificate Number : R0-CEP 2015-359 - Rev 01
Issue Date : 2022-08-09
Type : Chemical
Substance Number : 1295
Status : Withdrawn by Holder

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PharmaCompass offers a list of Calcifediol 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 Calcifediol manufacturer or Calcifediol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcifediol manufacturer or Calcifediol supplier.
A Dedrogyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dedrogyl, including repackagers and relabelers. The FDA regulates Dedrogyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dedrogyl 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 Dedrogyl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Dedrogyl supplier is an individual or a company that provides Dedrogyl active pharmaceutical ingredient (API) or Dedrogyl finished formulations upon request. The Dedrogyl suppliers may include Dedrogyl API manufacturers, exporters, distributors and traders.
click here to find a list of Dedrogyl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 13 companies offering Dedrogyl
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