Tag: Is FDA approval required in India?
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US FDA ANDA Drug Registration Form: How Generic Drug Companies File for Approval
Generic pharmaceutical companies seeking access to the United States market must submit an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA). The ANDA drug registration form and supporting documentation serve as the official regulatory submission through which a company demonstrates that its generic drug is equivalent to a previously approved…
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US FDA Registration Number: What It Means, How It Works, and Why It Matters
A US FDA Registration Number is a critical regulatory requirement for companies planning to manufacture, export, or sell regulated products in the United States. Despite its importance, many businesses misunderstand what this number represents, how it is issued, and what legal value it carries. This confusion often leads to compliance gaps, shipment delays, and regulatory…
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FDA Drug Establishment Registration: Guide for Global Pharmaceutical Companies
U.S. Food and Drug Administration drug establishment registration is a critical compliance requirement for pharmaceutical companies planning to manufacture or supply drugs to the United States. This process ensures that the FDA has full visibility of facilities involved in drug production and distribution, helping maintain safety, quality, and regulatory accountability across the U.S. drug supply…
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US FDA Consultants: Professional Guidance for Market Entry and Compliance
Companies planning to sell regulated products in the United States must comply with strict regulatory requirements enforced by the U.S. Food and Drug Administration. Understanding these rules without expert assistance can be challenging, especially for manufacturers based outside the US. This is where US FDA consultants provide critical value by simplifying compliance and ensuring regulatory…
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Professional US FDA Establishment Registration Database Services for Global Manufacturers by XPRO America
Introduction Entering or operating in the United States market requires more than product quality it demands precise regulatory compliance. For companies dealing in FDA-regulated products, US FDA establishment registration and database accuracy are fundamental compliance obligations that directly affect imports, inspections, and business continuity. The US FDA Establishment Registration Database is the FDA’s primary reference…
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US FDA Establishment Registration Database Services by XPRO America – Complete Compliance & Verification Support
Introduction For companies manufacturing, processing, packing, or holding products regulated by the United States Food and Drug Administration (US FDA), establishment registration is not optional—it is a mandatory compliance requirement. Whether you are a food exporter, pharmaceutical manufacturer, cosmetic brand, medical device company, or dietary supplement business, your establishment must be properly registered and accurately…