Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
01 1Curia
02 1Darmerica
03 1POLI INDUSTRIA CHIMICA SPA
04 1Piramal Pharma Solutions
01 1Italy
02 3U.S.A
01 1Inactive
02 3Blank
01 4Blank
01 4Blank
01 4Blank
01 4Blank
01 155486-1563
02 165085-0075
03 171052-828
04 1Blank
01 4Blank
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
NDC Package Code : 55486-1563
Start Marketing Date : 2012-06-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21157
Submission : 2007-12-17
Status : Inactive
Type : II
NDC Package Code : 71052-828
Start Marketing Date : 2021-03-30
End Marketing Date : 2030-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65085-0075
Start Marketing Date : 2022-08-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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A INCRELEX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of INCRELEX, including repackagers and relabelers. The FDA regulates INCRELEX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. INCRELEX API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A INCRELEX supplier is an individual or a company that provides INCRELEX active pharmaceutical ingredient (API) or INCRELEX finished formulations upon request. The INCRELEX suppliers may include INCRELEX API manufacturers, exporters, distributors and traders.
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