01 1M/s Medinex Laboratories Pvt. Ltd
01 1L Glutamic Acid hydrochloride USP
01 1WC-0279
01 1India
L Glutamic Acid hydrochloride USP
Date of Issue : 2021-10-05
Valid Till : 2024-06-24
Written Confirmation Number : WC-0279
Address of the Firm : Plot No. 2 & 3, Survey No. 277/1, Block No. 177/1, Village: Ukhrala-364005, Tehs...
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A (S)-2-Aminopentanedioate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (S)-2-Aminopentanedioate, including repackagers and relabelers. The FDA regulates (S)-2-Aminopentanedioate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (S)-2-Aminopentanedioate 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 (S)-2-Aminopentanedioate written confirmation ((S)-2-Aminopentanedioate WC) is an official document issued by a regulatory agency to a (S)-2-Aminopentanedioate manufacturer, verifying that the manufacturing facility of a (S)-2-Aminopentanedioate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (S)-2-Aminopentanedioate APIs or (S)-2-Aminopentanedioate finished pharmaceutical products to another nation, regulatory agencies frequently require a (S)-2-Aminopentanedioate WC (written confirmation) as part of the regulatory process.
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