FDA Wholesale License

Are you a pharmaceutical, cosmetic, or food business owner?

If so, obtaining an FDA wholesale license is essential for your success. But navigating the complex process can be overwhelming, with layers of paperwork, regulations, and inspections. 

This comprehensive guide will walk you through everything you need to know about obtaining an FDA wholesale license. From understanding the different types of licenses available to determine the eligibility criteria, we've got you covered. 

Discover the step-by-step process for submitting your application, including the necessary documentation and fees. Our team of experts has compiled a wealth of industry knowledge to provide practical tips and insider advice for each stage of the licensing journey.

Whether you're a seasoned entrepreneur or just starting, this guide will streamline the process, saving you time and minimizing stress. Achieve compliance, gain credibility, and unlock new opportunities by obtaining your FDA wholesale license today. Let's get started on your path to success.

What is meant by FDA?

The Food and Drug Administration (FDA) is a federal organization that was founded in 1906 when the Federal Food and Drugs Act was passed. Food, medicines, cosmetics, animal food, dietary supplements, medical devices, biological commodities, and blood products are among the departments that supervise most of the agency's responsibilities.

FDA Certification is one of the most important components, which figures out the product that you choose to market. Not all types of products can have access to FDA certification. Nonetheless, let us have a look at the same-

• A FDA certification is not required for food products, but is required for facilities that are registered with food businesses.
• Cosmetics and their ingredients do not require FDA certification. Cosmetics companies are no different. It is; however, wise to maintain the quality of cosmetic products for the safety of others. 
• FDA Certification for medical certification is placed into three risk-based categories by FDA. The categories are as follows-

1. Class I, Class II, and Class III.
2. There is a high risk associated with medical devices in the Class III category. 
3. These Class III devices only require Certification from FDA.
4. Assuring the FDA that Class III medical devices are safe and effective is the responsibility of the manufacturers.

The benefits of an FDA Wholesale License consist of the following points, which are as follows-

• Access to wider markets

FDA Wholesale License catalyses your growth and encourages you to reach wider audiences for recording growth and expansion. No wonder many healthcare institutions, businesses or pharmacies seek suppliers, and in that case, FDA license steps in to ensure compliance, allowing you to tap into markets offering potential benefits.  

• Competitive advantage

Businesses with FDA Wholesale licenses in India are highly valued compared to those without the same. In the case of the former, your existence in the market is considered competitive and justifies that you have complied with the necessary standards and guidelines. No wonder having FDA can set you apart from fellow competitors by making you more valuable in the marketplace. 

• Product Quality

To guarantee the quality and standards of pharmaceutical products, it is imperative to obtain FDA Wholesale licenses, which serve as a testament to your commitment in adhering to the guidelines. By adopting this approach, you can enhance your reputation and importance in the eyes of your target market and customers.

• Ensuring Legitimacy

With FDA Wholesale License, you can be assured of the Legitimacy and trustworthiness of the business. It proves that you have acted following the stringent rules and laws/ regulations. This can be true of the pharmaceutical industry, where safety and quality are paramount.

Hence, the points mentioned above hint towards the benefits of the FDAWholesale License.

The following documents are the pre-requisites for the application of a Drug Sales License under the Uttar Pradesh Drug License:

• An Affidavit attested by Public Notary:

1. Of Proprietor, if the applicant firm is a proprietorship firm.
2. Of all the partners, in case the firm is a partnership firm.
3. Of the person duly authorized by the Board of Directors of the Private Limited of Limited Company

• Copy of partnership deed if partnership firm
• Address proof of the authorized proprietor/applicant (copy of voter I.D., driving license)
• Affidavit of the liable person for day-to-day working and for any violation of laws pertaining to Drugs.
• Documents related to Pharmacist:

1. Affidavit duly attested by Public Notary.
2. Copies of educational qualification certificates (Attested)
3. Attested copy of registration certificate and its renewal issued by U.P. Pharmacy Council.
4. Two photographs per applied license.
5. Address proof.
6. Appointment letter and joining letter

• Documents related to a qualified person (for Wholesale license):

1. Attested copies of educational qualification certificates
2. Experience certificate on the affidavit
3. Two photographs per applied license
4. Appointment letter and Joining letter if applicable
5. Three copies of the plan of the proposed premises.

• Documentary proof of rental or ownership basis of the proposed premises

1. Photocopy of the rental agreement in case of rented premises.
2. Attested copy of ownership proof of rented premises from the landlord.

• Two photographs of the Proprietor/Partner/Authorized person.
• Attested copy of purchase invoice of a refrigerator

Requirements for Uttar Pradesh Drug Manufacture License

The following documents are the pre-requisites for the application of a Drug Manufacture License under the Uttar Pradesh Drug License:

• Affidavit of the following attested by Public Notary: -

1. Proprietor of the applicant firm, in case the firm is a proprietorship firm.
2. All the partners, in case the firm is a partnership firm.
3. The person duly authorized by the Board of Directors of the Private Limited or Limited Company.

• In case the applicant Company is a Private Limited or Limited Company, a copy of the minutes of the Board of Directors
• If Partnership firm, list of names and addresses of all partners. List of Board of Directors of Private Limited or Limited Company with full names and addresses of all directors.
• Attested copy of registration certificate from District Industries Centre if the applicant firm is a Small-Scale Unit.
• Partnership deed copy if partnership firm.
• Address proof of the authorized applicant/proprietor (Voter I.D, Driving license)
• Documents for Manufacturing Chemist Employed (not applicable if the license is required on Form 37 for a testing laboratory):

1. Affidavit duly attested by Public Notary
2. Attested copies of educational certificates, and experience certificates.
3. Attested copy of the letter of approval by the State Drugs Controller.
4. Copy of consent letter, appointment letter, or joining letter.
5. Medical certificate from a registered medical practitioner along with the eye fitness certificate.
6. Four photographs per applied license
7. Address proof

• Documents related to Analytical Chemist Employed:
• Affidavit duly attested by Public Notary
• Attested copies of educational certificates, experience certificates
• Attested copy of the letter of approval by the State Drugs Controller
• Copy of consent letter, appointment letter, or joining the letter
• Medical certificate from a registered medical practitioner along with the eye fitness certificate.
• Four photographs per applied license
• Address proof
• Attested copy of the consent of Approved testing laboratory that tests those raw materials and finished products which require sophisticated instruments for analysis
• Three copies of the Plan of Premises showing all the sections and dimensions.
• Documentary proof of ownership or rental basis of the proposed premises. Copy of rental agreement in case of rented premises. Attested copy of ownership proof of rented premises from the property owner
• Copy of No Objection Certificate (NOC) from Pollution Control Board.
• In case of renewal of license attested copy of Air and Water Consent from the Pollution Control Board (not applicable if the manufacturing unit is exempted for the same).
• Copy of test report of water from a Government Approved Laboratory regarding its portability and freedom from pathogenic microorganisms

If you wish to have a wholesale drug license from the directorate, then you ought to obtain renewal certificates in Form 21C (for Allopathic Drugs/ Schedule X Drugs), and 20-E (for Homoeopathic drugs) where the applicant should fill out forms 19,19B and 19C respectively along with additional information data.

While applying offline, the fees should be paid in the Government Treasury or Government Branch of State Bank of India of the district where the license is required. The original of the treasury challan must be submitted with the application.

With an extensive background and profound expertise in helping you obtain an FDA wholesale License, the Corpseed team has years of experience in this field. Our adeptness in the intricacies of the process enables us to provide comprehensive consultation services to our clients, encompassing meticulous desk-based research, thorough documentation, and efficient coordination. Our ultimate objective is to facilitate businesses in successfully navigating the registration process. Consequently, Corpseed stands as the ultimate solution for all your business requirements.