01 1Bio-Technology General (Israel) Ltd.
02 1Wasserburger Arzneimittelwerk GmbH
01 2Somatropin
01 1Sweden
02 1Blank
NDC Package Code : 62287-190
Start Marketing Date : 2015-03-04
End Marketing Date : 2027-01-29
Dosage Form (Strength) : POWDER, FOR SOLUTION (10mg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 84606-0824
Start Marketing Date : 2005-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER, FOR SOLUTION (10g/10g)
Marketing Category : BULK INGREDIENT
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A Somatropin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Somatropin, including repackagers and relabelers. The FDA regulates Somatropin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Somatropin 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 Somatropin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Somatropin supplier is an individual or a company that provides Somatropin active pharmaceutical ingredient (API) or Somatropin finished formulations upon request. The Somatropin suppliers may include Somatropin API manufacturers, exporters, distributors and traders.
click here to find a list of Somatropin 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 Somatropin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Somatropin 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 Somatropin 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 Somatropin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Somatropin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Somatropin suppliers with NDC on PharmaCompass.
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