CPC Scientific offers a variety of generic peptides and oligonucleotides used as active pharmaceutical ingredients (APIs). These generic APIs are utilized to treat a variety of diseases including cancer, diabetes, obesity, and multiple sclerosis. Our GMP manufacturing facility employs a rigorous quality and EHS system to ensure global compliance, including the stringent requirements of the United States, European Union, China, and Japan. We provide regulatory support, including DMF preparation, and serve as a one-stop solution for the drug development lifecycle, from discovery to commercial manufacturing. Our expertise in Generic (ANDA) and New Chemical Entity (NCE) development, including NDA submissions, offers efficient and reliable pathways for API regulatory approval, enabling seamless transitions from concept to commercialization.
Below is a listing of generic peptides that we currently provide or offer API development.
GENERIC PEPTIDE & OLIGO API DEVELOPMENT PIPELINE
Generic peptides & oligos* in development and with DMF documentation.
| API NAME | INDICATION | Early R&D | Late R&D | Process Validation | DMF Available | DMF SCHEDULE |
|---|---|---|---|---|---|---|
| Leuprorelin Acetate | ▪ Prostate and Breast Cancer ▪ Endometriosis ▪ Central Precocious Puberty | ✓ | ✓ | ✓ | ✓ | NMPA: Y20190007496(A) (2009) MFDS: 20200625-210-J-661 (2020) TFDA: 110DMF050097 |
| Triptorelin Acetate | ▪ Prostate and Breast Cancer ▪ Endometriosis ▪ Uterine Fibroids ▪ Assisted Reproduction | ✓ | ✓ | ✓ | ✓ | NMPA: Y20170001090(A) (2019) |
| Cetrorelix Acetate | ▪ In Vitro Fertilization (IVF) | ✓ | ✓ | ✓ | ✓ | NMPA: Y20190001147 (A) FDA: 034884 |
| Goserelin Acetate | ▪ Prostate and Breast Cancer ▪ Endometriosis ▪ Uterine Fibroids ▪ ART | ✓ | ✓ | ✓ | ✓ | NMPA: Y20230000413 (A) |
| Triptorelin Pamoate | ▪ Endometriosis ▪ Uterine Fibroids ▪ Premature Puberty ▪ Prostate Cancer ▪ ART | ✓ | ✓ | ✓ | NMPA: Q4 2025 | |
| Teduglutide | ▪ Short Bowel Syndrome | ✓ | ✓ | FDA: Q2 2026 |
Products under patent are not listed above. Please contact our team or reach out to [email protected] for inquiry.
Backed by nearly 25 years of experience in synthetic therapeutic development, CPC Scientific is a pioneering leader worldwide in peptide and oligonucleotide CDMO services, with an expanded focus on generic APIs. In the peptide and oligonucleotide field, these generics play a crucial role in expanding patient access and making advanced medicines more affordable. We are proud to serve as a trusted partner supporting our clients globally from development through commercial API production, in order to bring life-saving peptide NCE, oligonucleotide NCE, and generic API therapies to patients worldwide.
Backed by nearly 25 years of experience in synthetic therapeutic development, CPC Scientific is a pioneering leader worldwide in peptide and oligonucleotide CDMO services, with an expanded focus on generic APIs. In the peptide and oligonucleotide field, these generics play a crucial role in expanding patient access and making advanced medicines more affordable. We are proud to serve as a trusted partner supporting our clients globally from development through commercial API production, in order to bring life-saving peptide NCE, oligonucleotide NCE, and generic API therapies to patients worldwide.
