Tag: Is FDA approval required in India?
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US FDA ANDA Drug Registration Form: Complete Guide for Generic Drug Applicants
Companies planning to introduce generic drug products into the United States must submit an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA). The ANDA drug registration form is a critical part of this submission and serves as the formal mechanism through which applicants provide regulatory, scientific, and manufacturing information to…
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US FDA Registration Number Explained: Meaning, Process, Search, and Compliance Value
The US FDA Registration Number plays a central role in regulatory compliance for companies supplying products to the United States. From pharmaceuticals and medical devices to food, dietary supplements, and cosmetics, registration with the US FDA is a legal requirement for many businesses. Yet, confusion around what the registration number actually represents continues to cause…
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FDA Drug Establishment Registration: Practical Compliance Guide
U.S. Food and Drug Administration drug establishment registration is a foundational regulatory step for pharmaceutical companies aiming to enter or continue operations in the United States market. Any facility involved in drug manufacturing or related activities must be properly registered to ensure transparency, safety, and regulatory control within the U.S. drug supply chain. What Does…
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US FDA Consultants: Strategic Regulatory Partners for Global Businesses
Entering the United States market is a major opportunity for manufacturers and exporters, but it also comes with strict regulatory responsibilities. Products regulated by the U.S. Food and Drug Administration must meet detailed compliance standards before they can be legally marketed. For many companies, especially those operating outside the US, navigating these requirements without expert…
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US FDA Establishment Registration Database Compliance Services by XPRO America
Introduction For manufacturers, exporters, and brand owners targeting the United States, FDA compliance is not limited to product quality—it starts with accurate establishment registration. The US FDA Establishment Registration Database is the backbone of FDA oversight, import screening, and inspection planning. If your facility information is inaccurate, outdated, or improperly classified in the FDA database,…