About YARAL Pharma
YARAL Pharma is a wholly owned subsidiary of IBSA Pharma Inc. Established in 2022, YARAL Pharma specializes in the sale and distribution of authorized generics and generic products within the United States.
Founded in 1945, IBSA is a long-standing, multinational pharmaceutical company headquartered in Lugano, Switzerland. IBSA is:
• Recognized as a world leader in the development of innovative technologies and products that improve the health and wellness of people.
• Known for its manufacturing expertise and 50-year track record of product quality and supply continuity.
• Continually building a wide-ranging portfolio of products across brands and generics in ten core therapeutic areas.
The term “authorized generic” drug is most commonly used to describe an approved brand name drug that is marketed without the brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the branded product.
A generic drug is a copy of a brand-name drug that is developed and made by a company other than the company that manufactures the brand-name drug. A generic drug is the same as the brand-name drug in active ingredient, conditions of use, dosage form, strength, route of administration, and (with certain permissible differences) labeling. However, a generic drug may have certain minor differences from the brand-name product, such as different inactive ingredients.
An authorized generic drug is the same as the brand-name drug but does not use the brand name on the label. In addition, an authorized generic version of a tablet or capsule may have a different color or marking.
Authorized generic drugs are marketed under the brand name drug’s New Drug Application (NDA), and therefore are not listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book).
Yes, an authorized generic is considered to be therapeutically equivalent to its brand-name drug because it is the same drug. This is true even if the brand-name drug is “single source,” meaning there are no ANDAs approved for that product, or coded as non-equivalent (e.g., BN) by FDA in the Orange Book.