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Case 2:20cr00169RBS Document 2 Filed 05/07/20-Page 1 of 17IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIAUNITED STATES OF AMERICA:CRIMINAL NO: 20cr169:v. APEX CORP.:VIOLATION:
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Clearly mention the purpose of the admits and the specific products or drugs that the company manufactures or distributes.
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Provide information about the company's manufacturing facilities, certifications, and quality control procedures.
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Generic pharmaceutical company admits refer to the formal acknowledgment by a pharmaceutical firm that it produces and markets generic drugs, which are equivalent to brand-name medications in dosage form, strength, route of administration, quality, performance characteristics, and intended use.
All pharmaceutical companies that wish to market generic versions of branded drugs are required to file generic pharmaceutical company admits with the appropriate regulatory authority.
To fill out generic pharmaceutical company admits, companies must complete the official forms provided by the regulatory authority, providing detailed information about the generic product, including its chemical composition, manufacturing processes, and evidence of bioequivalence to the brand-name drug.
The purpose of generic pharmaceutical company admits is to ensure that generic drugs meet safety, efficacy, and quality standards, thus allowing them to be approved for sale in the market as alternatives to branded medications.
Information that must be reported on generic pharmaceutical company admits includes the drug's name, active ingredients, formulation, manufacturing sites, stability data, labeling information, and proof of bioequivalence to the brand-name drug.
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