Drug
Who makes atovaquone and proguanil hydrochloride?
9 companies list atovaquone and proguanil hydrochloride as a human prescription drug, including under the names MALARONE. Forms: tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing atovaquone and proguanil hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| GlaxoSmithKline Biologicals SAUnited Kingdom | tablet, film coated | NDANDA021078 | 2 | 19 |
| Mylan Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA202362 | 2 | 0 |
| Glenmark Pharmaceuticals Inc., USAIndia | tablet, film coated | ANDAANDA091211 | 1 | 9 |
| International Medication Systems, Ltd.United States | tablet, film coated | NDA AUTHORIZED GENERICNDA021078 | 1 | 3 |
| Bryant Ranch PrepackUnited States | tablet, film coated | ANDAANDA091211 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet, film coated | ANDAANDA202362 | 1 | 1 |
| Proficient Rx LPUnited States | tablet, film coated | ANDAANDA091211 | 1 | 1 |
| BluePoint Laboratories Inc. | tablet, film coated | ANDAANDA091211 | 1 | 0 |
| Prasco Laboratories | tablet, film coated | NDA AUTHORIZED GENERICNDA021078 | 1 | 0 |
Enquiry
Common questions
- Who makes atovaquone and proguanil hydrochloride?
- 9 companies list atovaquone and proguanil hydrochloride as a human prescription drug in the openFDA NDC Directory, led by GlaxoSmithKline Biologicals SA, Mylan Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc., USA, International Medication Systems, Ltd., Bryant Ranch Prepack. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic MALARONE?
- 6 companies list atovaquone and proguanil hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.