Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
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01 1Omgene Life Sciences Pvt. Ltd
02 1Sumar Biotech
03 1LGM Pharma
04 1Rochem International Inc
05 1Symbiotec Pharmalab
06 1Gonane Pharma
07 1Shanghai Minbiotech
08 1Fishfa Biogenics
09 1Apino Pharma
10 1Biocon
11 1Brawn Laboratories Ltd
12 1BrightGene Bio-Medical Technology Co.,Ltd
13 1Chongqing DaXin Pharmaceutical
14 2Concord Biotech
15 1Evotec
16 1Flax Laboratories
17 1Gufic Biosciences
18 1Huvepharma Italia S.r.l
19 1Mac-Chem Products (India) Pvt.Ltd
20 1Pfizer Inc
21 1Pliva Hrvatska
22 1Sichuan Xieli Pharmaceutical
23 1Tecoland Corporation
24 1Teva Pharmaceutical Industries
25 1Zhejiang Huida Biotech
26 1Zhejiang Tiantai Pharmaceutical
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01 7China
02 1Croatia
03 1Germany
04 12India
05 1Israel
06 1Italy
07 4U.S.A
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01 2Active
02 25Blank
01 27Blank
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01 27Blank
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01 1WC-0111
02 1WC-0256
03 1WC-0570
04 24Blank
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01 1No. 695-2-ND
02 1Su189-11-ND
03 1Su189-6-ND
04 24Blank
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01 10009-0043
02 111722-054
03 162227-007
04 165727-072
05 168254-0013
06 168254-0014
07 21Blank
01 27Blank
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Date of Issue : 2023-09-29
Valid Till : 2026-09-28
Written Confirmation Number : WC-0570
Address of the Firm :
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 : 32877
Submission : 2018-06-12
Status : Active
Type : II
NDC Package Code : 65727-072
Start Marketing Date : 2016-08-11
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 : 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
Registrant Name : Otran Pharm Korea Co., Ltd.
Registration Date : 2019-11-11
Registration Number : No. 695-2-ND
Manufacturer Name : BrightGene Pharmaceutical Co. Ltd.
Manufacturer Address : Building C25-C28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China
77
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A Ecalta manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ecalta, including repackagers and relabelers. The FDA regulates Ecalta manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ecalta 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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