Requirements of Pharmaceuticals Packaging

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The 5 labeling requirements of pharmaceuticals packaging

The Institute of Medicine reports poor labeling as a central cause for medication errors in the USA. In the pharmaceuticals realm, labeling serves as –

  • A snapshot of information for the consumer
  • As a guide for the safe use of the product
  • A branding tag for manufacturers which distinguishes their product from the rest crowding the aisles
  • And, as a legal requirement.

In most countries, there is a regulatory body that sets the labeling standards for pharmaceutical labels. This is why pharmaceutical manufacturers rely on labeling experts like Raja Tl who understand the unique labeling requirements in different countries across the globe.

The General Labelling Requirements

Regardless of which country it is, the following requirements must be fulfilled in every label for medicinal products –

1. An identity statement

Every drug and medical device comes with unique information that should be shown on the product. However, to remain compliant with the set guidelines, a manufacturer must include the following information in their label –

  • Official Product name
  • Brand name and logo
  • List of active and inactive ingredients along with their quantity in the product
  • Manufacturing license number
  • Manufacturing date and expiry date (they are usually reset daily and printed automatically)
  • Batch number of the production
  • Contact details of the manufacturer
  • Warnings
  • Instructions or direction of use
  • Dosage information
  • Barcode

Pharmaceutical manufacturers must keep in mind that misleading product identities will not only lead to the ban on their product but can also result in expensive legal battles.

2. A list of ingredients

Ingredients should be listed in decreasing order of predominance from most to least on every product.

Moreover for topical treatments, the strength or percentage of active ingredients in the formulation must be indicated.

It is also essential to represent the number of active ingredients in each unit of dose.

3. The format of the labels

Interestingly multiple studies have been done which look at the impact of design and format of labels.

And, such studies have been instrumental in setting some standard in terms of –

  • Font size and type
  • Appropriate use of language to frame claims, warnings, application, and more
  • The use of color and design
  • We at, Raja Tl, are well-versed in the requirements to formatting the perfect label for your product.

4. The material of the Label

One area that is not under strict scrutiny when it comes to labeling, is the type of material to be used.

However, we still prefer to deliver the best which is usually –

  • Quality White paper
  • Holographic films.
  • We also take special care of the adhesive to be used we make sure it is “low migration” meaning there will be minimum transfer of substances from the label to the drug or device.

5. Sustainability

The pharmaceutical industry generates a massive volume of waste. A matter of primary and pressing concern.

So, at Raja Tl, we try to mitigate that by mindful recycling and smart labeling that makes optimum use of the raw materials available to us.

So, whatever be your labeling needs, Raja Tl will customize their labeling services to fit your unique requirements.


401, 4th Floor, Himalaya house, 79, Palton Road, Fort, Mumbai, Maharashtra 400001


Phone: +91 02222611944
+91 02222610328
+91 9820324084 - Mr. Rohit Wala
+91 9820307328 - Mr. Pradyuman Jadeja (Director)


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