Alembic Pharma's Dapsone Gel is Off to Market with USFDA Approval

Alembic Pharma has secured the final approval from the USFDA for Dapsone Gel, 5 percent. That is the cure for acne vulgaris caused by excess oil clogged in the hair follicles and dead skin.

Alembic Pharmaceuticals holds a total cumulative of 244 Abbreviated New Drug Applications (ANDA) and 20 tentative approvals from the USFDA.

Some of the Recent Milestones

• Dapsone Gel, 5 percent- cure for acne vulgaris
• Osaltamivir Phosphate for Oral Suspension- for influenza treatment
• Larotrectinib Capsules- high-value oncology drug for solid tumors
• Binimetinib Tablets- for oncology therapy

The newly approved medicine for acne vulgaris is equivalent to Aczone Gel, 5 percent that is marketed by Almirall LLC. This approval enables Alembic to market the generic across the United States, giving patients an effective alternative to one of the common skin disorders.

Dapsone Gel helps in reducing the inflammation caused by acne vulgaris. This also becomes an alternative compared to the current branded treatment for the medical condition. But the safety and quality remain the same as the USFDA demands. Therefore, healthcare professionals are asked to refer to the Information regarding consumption and other indication details regarding the dosage of the medicine.

Also Read: Driving Vaccine Adoption Beyond Pediatric Immunization in India

Acne Vulgaris and Previous Treatments

Four major causes lead to acne vulgaris:

1. Excess sebum production
2. Disorder of Keratinization
3. Bacterial Colonization
4. Inflammation

The excess sebum is caused due to the over production of it, which often happens due to hormonal changes. And the abnormal keratinization is when the dead cells get mixed with the excess oil, leading to plugging the hair follicles. Similarly, the Cutibacterium acnes lives on skin that is in contact with excess oil, multiplies, and triggers immune responses. And lastly, the body’s reaction to clogged pores and bacteria causes the inflammation, resulting in redness of the skin. Previously, the treatments included Vitamin A derivatives, Topical Benzoyl peroxyl, to prevent clogged pores and fight bacteria. And for adult women, oral medications were effective as well.

What this Approval Means for the Company

This approval highlights the company’s consistent hard work in product development, regulatory compliance, and manufacturing excellence, allowing them to compete with the world’s best pharmaceuticals. This approval will thereby reflect in the company’s continued effort to produce and sell high-quality generic medicines across the globe. This also showcases the company’s effort in diversified product development, across multiple therapeutics, alongside addressing the need for affordable quality medicines.

Alembic Pharmaceuticals was established in 1907, headquartered in Vadodara, Gujarat. Till date, Alembic is India’s well established Pharmaceuticals, with more than a century of experience in research and development, and in the production of medicines. Its research and advanced manufacturing are approved by globally leading agencies like the USFDA itself.