Longshine Boi-Tech's active regulatory dossiers across the United States, European Union, Latin America, Japan, Korea, the Middle East and Africa. Filings are organised by jurisdiction; Letter of Authorization (LoA) is issued to qualified buyers at no charge for ANDA, IND, NDA, EU Marketing Authorisation, UK MHRA, ANVISA, PMDA and other regulatory submissions.
| Region | Filing type | Coverage | Status |
|---|---|---|---|
| United States | FDA Type II Drug Master File (DMF) | 60+ molecules — cardiovascular, anti-infective, oncology, CNS, endocrine, metabolic | Active |
| European Union | EDQM Certificate of Suitability (CEP) | Workhorse molecules — multiple Ph. Eur. monograph submissions | Active |
| European Union | Active Substance Master File (ASMF) | Non-CEP molecules — Restricted & Applicant's Part dossiers | Active |
| United Kingdom | UKMA + Windsor Framework ASMF | UK-specific recognition for EU-CEP-listed molecules | Active |
| Brazil | ANVISA RDC 359/2020 dossier | Portuguese-language CMC packages for Brazilian sponsors | Active |
| Canada | Health Canada DMF | Cross-referenced from US FDA DMFs | Active |
| Mexico | COFEPRIS sanitary registration support | Reference letters for Mexican filings | Active |
| Japan | PMDA Master File (J-DMF) | Selected molecules — JP-grade release | Submitted / In review |
| South Korea | MFDS Drug Master File | Selected molecules — KP-grade release | Submitted / In review |
| Russia | Roszdravnadzor | Per-molecule on buyer request | On request |
| China | NMPA | Per-molecule on buyer request | On request |
| Saudi Arabia, UAE | GCC SFDA dossier support | Reference letters and CMC packages | Active |
| South Africa | SAHPRA dossier | English-language CMC packages | Submitted / In review |
Once a supply agreement is in place with Longshine Boi-Tech, the Letter of Authorization is issued within 24 business hours by our QA Head, on company letterhead, with the active DMF / CEP / ASMF reference number, the molecule, the buyer's sponsor company and filing number, and the gateway address for direct regulatory submission. We support electronic gateway submission to FDA's ESG, EDQM's CESP, ANVISA's Solicita, and PMDA's electronic gateway.
Qualified buyers request the full Certificate of Analysis (CoA), Certificate of Origin (CoO), Certificate of GMP, ISO 9001:2015 certificate, FDA DMF Letter of Authorization, EDQM CEP, and Material Safety Data Sheet (SDS) as a single PDF bundle. Same-day turnaround once the mutual NDA is signed. Email regulatory@longshineboitech.com or open a request via the contact form.