1. US-Based Generic Drug Manufacturing

Type: Full manufacturing operation with complete control of production Timeline: 3-5 years to first product launch

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Cost: $15-100M+ initial investment

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Requirements:

• FDA-approved manufacturing facility
• ANDA filings for each product ($2-5M per application)
• GMP compliance systems
• Quality assurance infrastructure
• Regulatory affairs team
• Manufacturing personnel (30-50+ employees)

2. Virtual Pharmaceutical Company

Type: Drug ownership with outsourced manufacturing Timeline: 2-3 years to market

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Cost: $5-20M initial investment

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• Contract manufacturing partnerships
• ANDA filings for products
• Quality systems oversight
• Regulatory affairs team
• Distribution partnerships
• 10-20 employees (primarily regulatory and commercial)

3. Digital Pharmacy (Mark Cuban Model)