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01 1Indena
02 1Leo Pharma
03 1Sichuan Xieli Pharmaceutical
04 1Teva Pharmaceutical Industries
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01 1China
02 1Denmark
03 1Israel
04 1Italy
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02 1Inactive
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01 1No. 4726-1-ND
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01 147848-047
02 161200-037
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-23
Pay. Date : 2015-08-12
DMF Number : 29556
Submission : 2015-07-17
Status : Active
Type : II
NDC Package Code : 61200-037
Start Marketing Date : 2019-10-25
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER, FOR SUSPENSION (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28747
Submission : 2014-12-22
Status : Inactive
Type : II
Registrant Name : Leo Pharma Co., Ltd.
Registration Date : 2013-10-29
Registration Number : No. 4726-1-ND
Manufacturer Name : LEO Pharma Southport Pty Ltd
Manufacturer Address : 18 Olympic Circuit & 5 Goodyear Street, Southport, Queensland 4215, Australia
NDC Package Code : 47848-047
Start Marketing Date : 2013-11-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
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PharmaCompass offers a list of Ingenol Mebutate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ingenol Mebutate manufacturer or Ingenol Mebutate supplier for your needs.
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A 3-ingenol angelate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 3-ingenol angelate, including repackagers and relabelers. The FDA regulates 3-ingenol angelate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 3-ingenol angelate 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 3-ingenol angelate supplier is an individual or a company that provides 3-ingenol angelate active pharmaceutical ingredient (API) or 3-ingenol angelate finished formulations upon request. The 3-ingenol angelate suppliers may include 3-ingenol angelate API manufacturers, exporters, distributors and traders.
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