UPDATED WEEKLY FROM FDA RECORDS · LAST RUN OCT 30, 2026
FDA enforcement tracker for peptide suppliers
The FDA added 17 foreign drug makers to its import alerts in the last 90 days, most of them in China (9) and India (5). This page tracks those additions, warning letters that mention peptides, and every supplier in this directory with an FDA action on record.
Import alert additions by month
By the "date published" the FDA shows for each firm on 66-40, 66-79 and the drug entries of 66-41. A firm whose entry is revised may move to a later month.
Firms added to FDA import alerts, last 90 days
66-40: Drug GMP failures · 66-41: Unapproved drugs promoted in the US · 66-79: Refused FDA inspection or records
| Date | Firm | Alert |
|---|---|---|
| Oct 27, 2026 | COHESION BIOTEC PRIVATE LIMITEDIndia | 66-40Drug GMP failures |
| Oct 1, 2026 | Nanjing Chengong Pharmaceutical Co., Ltd.China | 66-40Drug GMP failures |
| Sep 30, 2026 | Shenzhen Benliju Bio-Tech Co., Ltd.China | 66-40Drug GMP failures |
| Sep 25, 2026 | Naturo Aid Pharmaceutical Inc.Canada | 66-41Unapproved drugs promoted in the US |
| Sep 23, 2026 | Horster Biotek Private LimitedIndia | 66-79Refused FDA inspection or records |
| Sep 21, 2026 | Sanrace Biotechnology Co., Ltd.China | 66-40Drug GMP failures |
| Sep 19, 2026 | Chengdu Shengnuo Biopharm Co., Ltd.China | 66-40Drug GMP failures |
| Sep 15, 2026 | Jiangsu Grand Xinyi Pharmaceutical Co., LtdChina | 66-79Refused FDA inspection or records |
| Sep 3, 2026 | PRITAM INTERNATIONAL PRIVATE LIMITEDIndia | 66-40Drug GMP failures |
| Aug 28, 2026 | Aurolab TrustIndia | 66-40Drug GMP failures |
| Aug 26, 2026 | Chongqing Qiancan Technology Co., Ltd.China | 66-79Refused FDA inspection or records |
| Aug 25, 2026 | Tianjin Healthcare Medical Technology Co., LtdChina | 66-79Refused FDA inspection or records |
| Aug 14, 2026 | TSP Solutions Pte. Ltd.Singapore | 66-40Drug GMP failures |
| Aug 13, 2026 | Rohto-Mentholatum (Vietnam) Co., Ltd.Vietnam | 66-40Drug GMP failures |
| Aug 11, 2026 | Shoolin Pharma Chem LLPIndia | 66-40Drug GMP failures |
| Aug 7, 2026 | Guangdong Bangze Medicine Co., LtdChina | 66-40Drug GMP failures |
| Aug 4, 2026 | Zhejiang Jifu Daily Chemical Co., Ltd.China | 66-40Drug GMP failures |
FDA warning letters mentioning peptides
Letters from the FDA drug center (CDER) about unapproved or misbranded drugs whose text names a peptide or research-use-only selling, posted in the last 12 months.
| Issued | Company | Mentions |
|---|---|---|
| Sep 24, 2026 | Cheap Medicine Shop/www.cheapmedicineshop.comUnapproved New Drugs/Misbranded (Internet Pharmacy) | semaglutide |
| Sep 23, 2026 | Online Generic Medicine/www.onlinegenericmedicine.comUnapproved New Drug/Misbranded (Internet Pharmacy) | peptide, semaglutide, GLP-1 |
| Sep 18, 2026 | Empower Clinic Services, LLC dba Empower PharmacyCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | semaglutide, tirzepatide |
| Aug 24, 2026 | TXP Innovations LLC dba Tex PeptidesUnapproved New Drugs/Misbranded | peptide, semaglutide, tirzepatide, retatrutide |
| Aug 24, 2026 | Royal Peptides LLCUnapproved New Drugs/Misbranded | peptide, semaglutide, tirzepatide, retatrutide |
| Aug 24, 2026 | NuScience Peptides LLCUnapproved New Drugs/Misbranded | peptide, semaglutide, retatrutide, survodutide |
| Aug 24, 2026 | Peptide Partners LLCUnapproved New Drugs/Misbranded | peptide, semaglutide, tirzepatide, retatrutide |
| Aug 24, 2026 | Peak Performance PeptidesUnapproved New Drugs/Misbranded | peptide, semaglutide, retatrutide, GLP-1 |
Listed suppliers with an FDA action on record
Each was matched by name and address to the FDA record before being added to its profile. An open action caps the supplier's confidence score; a closed one stays visible on the profile.
| Date | Supplier | Action | Status |
|---|---|---|---|
| Sep 19, 2026 | Chengdu Shengnuo BiopharmChina | Import Alert 66-40Dayi County, Chengdu facility; all drugs and drug products | Open |
| Sep 18, 2026 | Empower PharmacyUSA (TX) | MARCS-CMS 738238CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | Open |
| Sep 18, 2026 | Curia GlobalGlobal | 320-26-127CGMP for APIs; Rensselaer, NY facility (Curia New York), incomplete HPLC/UPLC laboratory data; not confirmed as a peptide API site | Open |
| Aug 24, 2026 | Peptide PartnersUSA | MARCS-CMS 735063Unapproved New Drugs/Misbranded | Open |
| Aug 24, 2026 | Royal PeptidesUSA / Canada | MARCS-CMS 734884Unapproved New Drugs/Misbranded | Open |
| Aug 18, 2026 | Reliance Life SciencesIndia (Navi Mumbai) | 320-26-117CGMP, finished pharmaceuticals; Navi Mumbai facility, inaccurate microbiology laboratory records | Open |
| Jul 9, 2026 | Reliance Life SciencesIndia (Navi Mumbai) | Import Alert 66-40Dhirubhai Ambani Life Sciences Centre, Navi Mumbai; all drugs and drug products manufactured by the company | Open |
| Jun 2, 2026 | Zydus LifesciencesIndia (Ahmedabad) | MARCS-CMS 722576CGMP, finished pharmaceuticals; Baddi, Himachal Pradesh facility, not a peptide API site | Open |
| May 1, 2026 | Harbin Jixianglong BiotechChina (Harbin) | Warning letterCGMP for APIs; relabeled semaglutide API from unapproved suppliers | Open |
| Feb 27, 2026 | Harbin Jixianglong BiotechChina (Harbin) | Import Alert 66-40All drugs and drug products | Open |
| Jan 16, 2026 | BiopeptekUSA (Malvern, PA) | Import Alert 66-79Qingdao, Shandong facility; firm refused FDA inspection; all drugs and drug products. We have not confirmed which site makes Biopeptek peptide APIs | Open |
| Dec 8, 2025 | DarmericaUSA (FL) | 320-26-24CGMP for APIs, Davie, FL facility; distributed retatrutide and other unapproved peptide APIs for compounding, GLP-1 APIs received labeled as "custom peptide", sourced from a supplier not registered with FDA | Open |
| Dec 10, 2024 | Swiss ChemsUSA (NY) | MARCS-CMS 695663Unapproved New Drugs/Misbranded | Open |
| Aug 29, 2024 | Zydus LifesciencesIndia (Ahmedabad) | MARCS-CMS 685224CGMP, finished pharmaceuticals; Jarod, Gujarat facility, not a peptide API site | Closed Dec 9, 2025 |
| Jun 18, 2024 | Sun Pharmaceutical IndustriesIndia (Mumbai) | MARCS-CMS 677337CGMP, finished pharmaceuticals; Dadra facility, not a peptide API site | Open |
| Nov 17, 2023 | CiplaIndia (Mumbai) | Warning letterPithampur, Madhya Pradesh finished-dose facility, not a peptide API site | Open |
| Dec 7, 2022 | Sun Pharmaceutical IndustriesIndia (Mumbai) | Import Alert 66-40Halol, Gujarat facility; Karkhadi listed since 2014 and former Ranbaxy sites at Paonta Sahib and Dewas since 2009; we have not confirmed which site makes its peptide APIs | Open |
| Feb 16, 2021 | Shilpa PharmaIndia | Import Alert 66-40Jadcherla, Telangana formulations facility, not confirmed as a peptide API site | Open |
| Feb 12, 2020 | CiplaIndia (Mumbai) | Warning letterGoa finished-dose facility, re-inspected and classed VAI in June 2024 | Open |
| Oct 8, 2013 | GL Biochem (Shanghai)China | Import Alert 66-41519 Zi Yue Road, Shanghai; cosmetics (FDA product code 53) under the alert for unapproved new drugs promoted in the US. Peptide APIs and research peptides are not named in the entry | Open |
Sources and method
Import alert data is read every Thursday from the FDA red lists for Import Alert 66-40, Import Alert 66-41, Import Alert 66-79. Entries on 66-41 are limited to human drug products; its food and cosmetic entries are left out. Warning letters are read every Wednesday from the FDA warning letter database and kept when the letter text mentions a peptide or research-use-only selling.
A firm's presence here is the FDA's finding, not ours. To vet a specific manufacturer, use the GMP lookup tool or compare suppliers with a clean record on the top verified peptide suppliers list.
Frequently asked questions
What does an FDA import alert mean for a peptide buyer?
Products from a firm on an import alert can be detained at the US border without physical examination. For buyers, an import alert on a drug or API maker means shipments into the US are likely to be held, and on 66-40 it means the FDA found the firm did not meet drug GMP.
Is every firm on this page a peptide manufacturer?
No. Import alerts 66-40 and 66-79 cover all drug makers, so many entries make OTC drugs, cosmetics or supplements. Check each firm's FDA record to judge whether it matters for your supply chain. Warning letters are only included if the letter text mentions peptides.
How often is the tracker updated?
Weekly. Warning letters are checked every Wednesday and import alerts every Thursday, and the page rebuilds from the FDA lists automatically.
What happens when a listed supplier appears on an alert?
We check the firm name and address against the FDA record before changing anything. Once confirmed, the action is shown on the supplier's profile and caps its confidence score until the FDA closes it.