Drug
Who makes sirolimus?
20 companies list sirolimus as a human prescription drug, including under the names FYARRO, HYFTOR. Forms: gel; injection, powder, lyophilized, for suspension; solution; tablet; tablet, film coated; tablet, sugar coated. Routes: intravenous, oral, topical.
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 sirolimus
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| RemedyRepack, IncUnited States | tablet; tablet, film coated | ANDAANDA201578, ANDA201676, ANDA208691 | 4 | 1 |
| Mylan Pharmaceuticals, Inc. | solution; tablet, sugar coated | NDA AUTHORIZED GENERICNDA021083, NDA021110 | 4 | 0 |
| Northstar Rx, LLC, | solution; tablet, film coated | ANDAANDA208691, ANDA216728 | 4 | 0 |
| Zydus Lifesciences LimitedIndia | tablet, film coated | ANDAANDA201676 | 3 | 12 |
| Glenmark Pharmaceuticals Inc., USAIndia | tablet, film coated | ANDAANDA208691 | 3 | 9 |
| Zydus Pharmaceuticals USA Inc.India | tablet, film coated | ANDAANDA201676 | 3 | 1 |
| ASCEND Therapeutics US, LLC | tablet, film coated | ANDAANDA214753 | 3 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | tablet | ANDAANDA201578 | 2 | 15 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet; tablet, film coated | ANDAANDA201578, ANDA201676 | 2 | 5 |
| Apotex Inc.Canada | solution | ANDAANDA211406 | 1 | 6 |
| Bryant Ranch PrepackUnited States | solution | ANDAANDA216728 | 1 | 1 |
| Camber Pharmaceuticals, Inc.United States | solution | ANDAANDA215080 | 1 | 1 |
| Rising Pharma Holdings, Inc.United States | solution | ANDAANDA215116 | 1 | 1 |
| Aadi Bioscience, Inc. | injection, powder, lyophilized, for suspension | NDANDA213312 | 1 | 0 |
| Amneal Pharmaceuticals NY LLC | solution | ANDAANDA211212 | 1 | 0 |
| AvPAK | tablet | ANDAANDA201578 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA214753 | 1 | 0 |
| Nobelpharma America, LLC | gel | NDANDA213478 | 1 | 0 |
| Novadoz Pharmaceuticals LLC | solution | ANDAANDA216728 | 1 | 0 |
| VistaPharm, LLC | solution | ANDAANDA211040 | 1 | 0 |
Bulk ingredient listings
- AX Pharmaceutical CorpCanada · 2 NDC
- Biocon Biologics LimitedIndia · 1 NDC
- Chongqing Daxin Pharmaceutical Co., Ltd.China · 1 NDC
- Concord Biotech LimitedIndia · 1 NDC
- Curia India Private LimitedItaly · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Fujian Kerui Pharmaceutical Co., Ltd. · 1 NDC
- Hisun Pharmaceutical (Hangzhou) Co., Ltd. · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.China · 1 NDC
- North China Pharmaceutical Huasheng Co. Ltd.China · 1 NDC
- Qingdao Biopeptek Co LtdChina · 1 NDC
- Qingdao Qinzeyuan Biotechnology Co LtdChina · 1 NDC
- Sumar Biotech LLPIndia · 1 NDC
- Suresource Pharma LLCUnited States · 1 NDC
- Zhejiang Wild Wind Pharmaceutical Co.,Ltd.China · 1 NDC
Orange Book patents
7 unexpired patents list sirolimus as the active ingredient, expiring between Feb 2029 and Oct 2040. Application holder: AADI BIOSCIENCES INC.
Enquiry
Common questions
- Who makes sirolimus?
- 20 companies list sirolimus as a human prescription drug in the openFDA NDC Directory, led by RemedyRepack, Inc, Mylan Pharmaceuticals, Inc., Northstar Rx, LLC,, Zydus Lifesciences Limited, Glenmark Pharmaceuticals Inc., USA. 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 FYARRO?
- 17 companies list sirolimus under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies sirolimus active ingredient?
- 16 companies list sirolimus as a bulk ingredient, including AX Pharmaceutical Corp, Biocon Biologics Limited, Chongqing Daxin Pharmaceutical Co., Ltd., Concord Biotech Limited.