Regulatory Affairs
Global End-to-End RA Services, from Pre-Clinical and Clinical Studies to Product Launches
Regulatory
Our Responsibilities
Sinopep's Regulatory Affairs (RA) team works closely with all relevant functional organizations to provide global end-to-end RA services to our partners, from pre-clinical and clinical studies to product launches, including regulatory strategy consulting, technical review, dossier preparation and submission, as well as communication with regulatory agencies. The core RA team members have at least 15 years of drug registration experience, are familiar with the regulations and technical requirements of FDA, NMPA, EDQM, PMDA, etc.
Our well-trained RA staff are very familiar with different electronic submission systems in various countries and regions.
Inspection History
Since 2014, Sinopep’s GMP manufacturing facilities have successfully passed four (4) inspections conducted by the U.S. FDA, demonstrating our strong commitment to global regulatory compliance and product quality. In addition to these FDA audits, Sinopep has also undergone inspections by the Korean MFDS and has successfully completed 20 regulatory audits conducted by the NMPA in China.
| Date | Inspected Product | Inspection Type | Result |
|---|---|---|---|
| Apr 2014 | Peptide API (Eptifibatide) | FDA CGMP | Pass |
| Apr 2016 | Peptide API (Eptifibatide, Lanreotide acetate) | FDA CGMP | Pass |
| Jan 2019 | Peptide API (Eptifibatide, Lanreotide acetate, Bivalirudin, Octreotide acetate) | FDA CGMP | Pass |
| Nov 2023 | Small Molecule & Peptide API | MFDS CGMP | Pass |
| Sep 2024 | Peptide API (Tirzepatide, Semaglutide, Liraglutide, Cetrorelix acetate, Eptifibatide, Octreotide acetate, Bivalirudin, Lanreotide acetate, Desmopressin Acetate) - Unannounced Inspection | FDA CGMP | Pass |
| July 2025 | Semaglutide & Liraglutide | ANVISA CGMP | Pass |
Regulatory Experience
Over the years, Sinopep has filed over 100 dossiers to regulatory agencies such as FDA, NMPA, EDQM and PMDA covering ANDA, DMF, CEP and VMF submissions. There has been no delay or failure on deficiency response in any of our filings. Today, our APls and pharmaceutical products have been successfully marketed in over 40 countries.
- 100+ Dossiers filed to regulatory agencies
- 40+ APIs or Pharmaceutical Products Marketed
DMF Filing Status (US FDA)
| Submission | DMF No. | Registration Status |
|---|---|---|
| Liraglutide | 034104 | FA Letter received from US-FDA |
| Semaglutide | 036273 | FA Letter received from US-FDA |
| Tirzepatide | 039465 | US DMF was submitted in 2024 |
| Eptifibatide | 023786 | Approved by FDA |
| Bivalirudin | 032281 | Approved by FDA |
| Lanreotide Acetate | 029693 | Approved by FDA |
| Octreotide Acetate | 029710 | Approved by FDA |
| Fulvestrant | 033902 | Approved by FDA |
| Cetrorelix acetate | 035171 | FA Letter received from US-FDA |
| Desmopressin Acetate | 037799 | US DMF was submitted in Dec. 2022 |
| Oseltamivir Phosphate | 033907 | FA Letter received from US-FDA |
DMF Filing Status (NMPA)
| Submission | DMF No. | Registration Status |
|---|---|---|
| Liraglutide | Y20220000633 | Under technical review |
| Semaglutide | Y20220001086 | Under technical review |
| Octreotide Acetate | Y20180001746 | Approved by related authority |
| Bivalirudin | Y20190000290 | Approved by related authority |
| Eptifibatide | Y20180001360 | Approved by related authority |
| Fulvestrant | Y20200001489 | Approved by related authority |
| Alagliptin benzoate | Y20180000506 | Approved by related authority |
| Oseltamivir Phosphate | Y20200000736 | Approved by related authority |
| Albuvirtide | Y20200001298 | Approved by related authority |
| Thymalfasin | Y20170001373 | Approved by related authority |
| Desmopressin Acetate | Y20220001250 | Under technical review |
| Cetrorelix acetate | Y20220000567 | Under technical review |
| Epalrestat | Y20220001175 | Under technical review |
| Atorvastatin calcium | Y20210001031 | Under technical review |
| Sodium Picosulfate | Y20220000698 | Under technical review |
New Heights
Start your Journey with Sinopep
Comprehensive GMP manufacturing and formulation capabilities to support your projects across all stages—from early discovery and late-phase development through to full commercialization.
