Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1Gonane Pharma
03 1Arcadia Lifescience
04 1Arihantanam Life Care
05 1Cipla
06 1Globofarm International
07 1Huvepharma Italia S.r.l
08 1Ipca Laboratories
09 2Mangalam Drugs & Organics Ltd
10 1Micro Orgo Chem
11 1Nishchem International Pvt. Ltd
12 1Olon S.p.A
13 1Sibbiotech
14 1Skant Healthcare Ltd.
15 1Solara Active Pharma Sciences
16 2Vaishali Pharma Ltd
17 1Vital Health Care Pvt. Ltd
18 1Vital Laboratories Private Limited
01 1Canada
02 1France
03 15India
04 2Italy
05 1Russia
01 2Active
02 3Inactive
03 15Blank
01 20Blank
01 20Blank
01 1WC-0091
02 1WC-0143n
03 1WC-0167
04 1WC-0319
05 1WC-0473
06 1WC-303
07 14Blank
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 : 27825
Submission : 2013-12-16
Status : Inactive
Type : II
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31686
Submission : 2017-04-07
Status : Active
Type : II
Registrant Name : Shin Poong Pharmaceutical Co., Ltd.
Registration Date : 2021-01-15
Registration Number : Number 1414-8-ND
Manufacturer Name : Huvepharma Italia Srl
Manufacturer Address : Via R. Lepetit, 142 12075 - GARESIO (CN) ITALY
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24028
Submission : 2010-08-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22218
Submission : 2009-01-22
Status : Inactive
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0091
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20188
Submission : 2008-04-15
Status : Inactive
Type : II
Date of Issue : 2022-07-05
Valid Till : 2025-09-08
Written Confirmation Number : WC-0143n
Address of the Firm :
NDC Package Code : 53104-7630
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-10-22
Valid Till : 2022-10-22
Written Confirmation Number : WC-303
Address of the Firm :
Date of Issue : 2022-05-20
Valid Till : 2025-01-13
Written Confirmation Number : WC-0319
Address of the Firm :
Date of Issue : 2022-10-27
Valid Till : 2025-07-22
Written Confirmation Number : WC-0167
Address of the Firm :
Date of Issue : 2020-06-11
Valid Till : 2023-06-10
Written Confirmation Number : WC-0473
Address of the Firm :
A Artesunate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Artesunate, including repackagers and relabelers. The FDA regulates Artesunate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Artesunate 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 Artesunate supplier is an individual or a company that provides Artesunate active pharmaceutical ingredient (API) or Artesunate finished formulations upon request. The Artesunate suppliers may include Artesunate API manufacturers, exporters, distributors and traders.
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