Skip to the page

Data / Drug companies / Sirolimus

Sirolimus: 22 companies and 40 products in the FDA NDC directory

Sirolimus is listed in the FDA National Drug Code Directory by 22 companies, with 40 products in commercial distribution. 34 of the products (85.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; solution; tablet, and the newest product started marketing on October 27, 2026.

SpecStream is the live web data engine for teams and agents. It reads the National Drug Code Directory that FDA publishes, and this page is that reading. Ask for the companies that make a drug, a class or a dosage form, with their headquarters, website and size added from the web, and new listings and discontinued products arrive in your sheet, CRM, Slack or agent as FDA posts them.

Companies listing it
22
Products
40
Generic (ANDA) products
34 (85.0%)
Application numbers
14
Routes
Oral, Topical, Intravenous
Brand names
Hyftor, Fyarro
openFDA record search
api.fda.gov

Companies that list sirolimus

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Mylan Pharmaceuticals Inc.4tablet, sugar coated; solutionAuthorized generics (NDA)July 22, 2019
Remedyrepack Inc.4tablet; tablet, film coatedGeneric drugs (ANDA)August 19, 2025
Ascend Laboratories, LLC3tablet, film coatedGeneric drugs (ANDA)March 13, 2021
Glenmark Pharmaceuticals Inc., USA3tablet, film coatedGeneric drugs (ANDA)October 16, 2020
NorthStar Rx LLC3tablet, film coatedGeneric drugs (ANDA)October 18, 2021
Zydus Lifesciences Limited3tablet, film coatedGeneric drugs (ANDA)February 16, 2023
Zydus Pharmaceuticals USA Inc.3tablet, film coatedGeneric drugs (ANDA)February 16, 2023
AvPAK2tablet; tablet, film coatedGeneric drugs (ANDA)October 27, 2026
Dr. Reddy's Laboratories Limited2tabletGeneric drugs (ANDA)October 27, 2014
Aadi Bioscience, Inc.1injection, powder, lyophilized, for suspensionNew drug applications (NDA)December 6, 2021
American Health Packaging1tabletGeneric drugs (ANDA)November 5, 2015
American Health Packaging1tablet, film coatedGeneric drugs (ANDA)June 2, 2026
Amneal Pharmaceuticals NY LLC1solutionGeneric drugs (ANDA)October 25, 2019
Apotex Corp.1solutionGeneric drugs (ANDA)May 20, 2020
Bryant Ranch Prepack1solutionGeneric drugs (ANDA)January 19, 2023
Camber Pharmaceuticals, Inc.1solutionGeneric drugs (ANDA)September 16, 2024
Major Pharmaceuticals1tablet, film coatedGeneric drugs (ANDA)March 13, 2021
Nobelpharma America, LLC1gelNew drug applications (NDA)March 23, 2022
NorthStar RxLLC1solutionGeneric drugs (ANDA)January 19, 2023
Novadoz Pharmaceuticals LLC1solutionGeneric drugs (ANDA)January 19, 2023
Rising Pharma Holdings, Inc.1solutionGeneric drugs (ANDA)July 15, 2025
VistaPharm, LLC1solutionGeneric drugs (ANDA)January 28, 2019

Dosage forms

Dosage formProductsShare
Tablet, film coated2050%
Solution922.5%
Tablet615%
Tablet, sugar coated37.5%
Gel12.5%
Injection, powder, lyophilized, for suspension12.5%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)3485%
Authorized generics (NDA)410%
New drug applications (NDA)25%

Pharmacologic classes

Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.