To establish a pharmaceutical company in New York, you’ll need to obtain several key licenses and permits. Here are the main ones:
- Drug Manufacturing License:
- Issued by the New York State Board of Pharmacy, this license is required to manufacture pharmaceutical products within the state[1].
- Drug Sales License:
- Necessary for the distribution and sale of pharmaceutical products. This ensures compliance with state regulations on drug sales[1].
- Controlled Substances License:
- If your company handles controlled substances, you will need a specific license from the New York Department of Health – Bureau of Narcotic Enforcement[2].
- Clinical Trial Authorization:
- Before marketing new drugs, you must conduct clinical trials and obtain approval from the relevant regulatory body[2].
- Environmental and Safety Permits:
- Depending on your operations, you may need permits related to environmental impact and workplace safety[2].
- Business Registration:
- Register your company with the New York State Department of State and obtain a tax identification number[2].
These licenses ensure that your pharmaceutical company operates legally and maintains high standards of quality and safety.
References
[1] NYS Pharmacy:Pharmacy Establishments:Resident In State Pharmacy …
[2] New York Healthcare and Pharmaceutical Licensing – Harbor Compliance