Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
01 1Omgene Life Sciences Pvt. Ltd
02 1LGM Pharma
03 1Rochem International Inc
04 1Symbiotec Pharmalab
05 1Gonane Pharma
06 1Shanghai Minbiotech
07 1Fishfa Biogenics
08 1Biocon
09 1Brawn Laboratories Ltd
10 1BrightGene Bio-Medical Technology Co.,Ltd
11 1Chongqing DaXin Pharmaceutical
12 1Concord Biotech
13 1Gufic Biosciences
14 1Huvepharma Italia S.r.l
15 1Mac-Chem Products (India) Pvt.Ltd
16 1Sumar Biotech
17 1Tecoland Corporation
18 1Teva Pharmaceutical Industries
19 1Zhejiang Huida Biotech
20 1Zhejiang Tiantai Pharmaceutical
01 5China
02 10India
03 1Israel
04 1Italy
05 3U.S.A
01 2Active
02 18Blank
01 20Blank
01 20Blank
01 1WC-0111
02 1WC-0256
03 18Blank
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32010
Submission : 2017-08-28
Status : Active
Type : II
NDC Package Code : 62227-007
Start Marketing Date : 2015-07-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32877
Submission : 2018-06-12
Status : Active
Type : II
NDC Package Code : 65727-072
Start Marketing Date : 2016-08-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2021-04-12
Valid Till : 2024-01-28
Written Confirmation Number : WC-0256
Address of the Firm :
Date of Issue : 2019-09-23
Valid Till : 2022-07-02
Written Confirmation Number : WC-0111
Address of the Firm :
NDC Package Code : 68254-0013
Start Marketing Date : 2014-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1mg/mg)
Marketing Category : BULK INGREDIENT
A Anidulafungin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Anidulafungin, including repackagers and relabelers. The FDA regulates Anidulafungin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Anidulafungin 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 Anidulafungin supplier is an individual or a company that provides Anidulafungin active pharmaceutical ingredient (API) or Anidulafungin finished formulations upon request. The Anidulafungin suppliers may include Anidulafungin API manufacturers, exporters, distributors and traders.
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