Private labeling in the pharmaceutical industry has become an increasingly popular business model in recent years. Private labeling refers to the practice of a company manufacturing a product, which is then sold under another company’s brand name. Essentially, the manufacturer produces the product and allows another company to attach its own label to it.

Private labeling is a common practice used by companies to expand their product offerings without having to invest in the research and development (R&D) required to create a new medicinal product. The company that sells private label products may have a well-established brand name and reputation in the market. The manufacturer can thereby benefit from the practice by providing the private labeling company with a quality product that can be sold under the more established brand name.

Private labeling can also pave the way for smaller pharmaceutical companies to enter the market by using the manufacturing capabilities of a larger company to produce their products. This can help them compete with larger pharmaceutical companies and reach a wider audience.

It is important to note that private-label products are still subjected to the same Regulatory requirements and quality standards as any other pharmaceutical product. The manufacturer is responsible for ensuring that the product is safe and effective and that it meets all the Regulatory requirements.

Table 1: Adoption of Private Labeling: Challenges and Solutions

Sr No.

Private Labeling Aspects




 Quality Control

One of the biggest challenges faced by pharmaceutical companies when adopting private labeling is maintaining quality control. Since the manufacturing process is outsourced to a contract manufacturer, the company must rely on the manufacturer regarding adherence to strict quality control standards.

If the contract manufacturer fails to meet the necessary standards, the reputation of the private-label brand could be damaged.

Pharmaceutical companies need to conduct thorough due diligence on potential contract manufacturers before entering a partnership.

They should also establish clear quality control standards and ensure the manufacturer adheres to them.


Regulatory Compliance

Another challenge for pharmaceutical companies is ensuring that their private-label products meet all the Regulatory requirements. This includes:

  • Obtaining Regulatory approval for the product
  • Maintaining proper documentation
  • Adhering to Good Manufacturing Practices (GMPs)

Pharmaceutical companies need to work closely with their contract manufacturers to ensure that all the Regulatory requirements are met. This includes:

  • Conducting regular audits of the manufacturing facilities to ensure compliance with GMPs
  • Maintaining detailed documentation of the entire manufacturing process


Brand Management

Another challenge for pharmaceutical companies when adopting private labeling is brand management. Since the product is sold under the pharma company’s brand name, the company must ensure that the private-label brand aligns with its own brand values and messaging.

Pharmaceutical companies should carefully select contract manufacturers that align with their brand values and messaging. They should also provide clear guidelines for private-label branding and ensure that the manufacturer adheres to these guidelines.


Price and Margin Control

Pharmaceutical companies may also face challenges in controlling the pricing and margins of their private-label products. Since the manufacturing and distribution process is outsourced, the company may have less control over the pricing and margins of the product.

Pharmaceutical companies should establish clear pricing and margin guidelines with their contract manufacturers. They should also closely monitor the pricing of their private-label products to ensure that the products are competitive in the market.


Intellectual Property Protection

When using a contract manufacturer for private labeling, pharmaceutical companies must ensure that their intellectual property is protected. This includes:

  • Product Formulation
  • Packaging Design
  • Branding

If the contract manufacturer uses this information without permission or shares it with others, it could result in lost sales and damage to the brand's reputation.

Pharmaceutical companies should work with their contract manufacturers to establish clear agreements regarding Intellectual Property Rights. They should also conduct regular audits to protect their intellectual property.


Supply Chain Management

Pharmaceutical companies may also face challenges in managing their supply chain when adopting private labeling. Since the manufacturing and distribution process is outsourced, it can be difficult to track inventory levels, manage shipments, and maintain proper storage conditions.

Pharmaceutical companies should establish clear Supply Chain Management procedures with their contract manufacturers. This includes:

  • Setting inventory levels
  • Establishing shipping protocols
  • Ensuring that the products are stored and transported in appropriate conditions.


Product Development

When adopting private labeling, pharmaceutical companies may face challenges in developing new products. Since the manufacturing process is outsourced, it can be difficult to make changes to the product formulation, packaging design, or any other features.

Pharmaceutical companies should work closely with their contract manufacturers to ensure that the product development process is effective. This includes:

  • Providing clear guidelines for product specifications
  • Establishing timelines for product development
  • Ensuring that the manufacturer is responsive to feedback and suggestions


Market Competition

Pharmaceutical companies may face challenges in competing with other private-label products in the market. Since private labeling is a common practice in the Pharmaceutical industry, there may be many similar products available to consumers.

Pharmaceutical companies should focus on differentiating their private-label products from other products in the market. This includes:

  • Emphasizing the unique features of the private-label product
  • Offering competitive pricing
  • Building strong brand recognition and customer loyalty

Source: Created by the Author

To sum up, the above table highlights that one of the major Regulatory requirements for private-label pharmaceutical products is GMPs, which ensure that the product is manufactured and tested to meet strict quality standards. The manufacturer must also obtain Regulatory approval for the product and maintain proper documentation to demonstrate compliance with all the Regulatory requirements.

Private labeling has become a common practice in many countries around the world, including the United States (US), Canada, Europe, India, China, and Japan. Pharmaceutical companies can succeed in implementing this business model by understanding the benefits and challenges of private labeling and complying with the regional Regulatory requirements.

Partnering with an experienced service provider can pave the way for complying with all the regional requirements of the Health Agencies and getting the right guidance to address the challenges. Contact Freyr now for Regulatory assistance!


Nirupama Parate


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