Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab Private Limited
02 1DARMERICA, LLC
03 1Kalchem International inc
04 1Professional Compounding Centers of America dba PCCA
05 1Professional Compounding centers of America
06 2Qinhuangdao Zizhu Pharmaceutical Co., Ltd.
01 3ESTRONE
02 1ESTRONE MICRONIZED
03 3Estrone
01 2China
02 1India
03 2U.S.A
04 2United Kingdom
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
NDC Package Code : 22552-0022
Start Marketing Date : 2011-05-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 71052-548
Start Marketing Date : 2019-07-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1000g/1000g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 60592-208
Start Marketing Date : 2019-11-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51927-0316
Start Marketing Date : 2023-09-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 51927-1709
Start Marketing Date : 2013-06-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 44132-003
Start Marketing Date : 2014-10-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 44132-011
Start Marketing Date : 2014-06-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Estrone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Estrone, including repackagers and relabelers. The FDA regulates Estrone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Estrone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Estrone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Estrone supplier is an individual or a company that provides Estrone active pharmaceutical ingredient (API) or Estrone finished formulations upon request. The Estrone suppliers may include Estrone API manufacturers, exporters, distributors and traders.
click here to find a list of Estrone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Estrone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Estrone API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Estrone as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Estrone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Estrone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Estrone suppliers with NDC on PharmaCompass.
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