Frequently Asked Questions

Yes. Sunytex Pharmaceuticals is an FDA-registered 503B outsourcing facility operating under full current Good Manufacturing Practices (cGMP). Our facility meets all FDA requirements and is regularly inspected to ensure strict compliance with quality, documentation, and production standards.
Every product is tested and released by an independent Quality Unit. We perform 100% batch release testing—including sterility, potency, and endotoxin—and maintain 21 CFR Part 11-compliant electronic records. Clients receive Certificates of Analysis (CoAs), validated methods, and audit-ready reports for every batch.

Absolutely. We specialize in custom formulations tailored to your specifications, as well as private label manufacturing under your brand. We offer full-service support from formulation and manufacturing to packaging and labeling.
Our lab offers a wide range of analytical, microbiological, and stability testing services: - Analytical Testing: Potency (HPLC/UPLC), impurities, pH, osmolality, water content, etc. - Microbiology: Sterility (USP <71>), rapid methods, endotoxin (LAL), bioburden (USP <61>/<62>), AET (USP <51>), environmental monitoring. - Stability Testing: ICH long-term and accelerated studies, freeze-thaw cycles, in-use studies, stability-indicating method validation.
Yes. We offer pre-formulation, formulation development, excipient compatibility studies, and dosage form optimization. Our R&D team supports IND, NDA, ANDA, and BLA submissions with robust data and integrated method development and validation.
We offer end-to-end cGMP manufacturing services for sterile and non-sterile drug products. Our capabilities include aseptic filling of injectables (vials, prefilled syringes), oral solutions, and topical formulations. As a 503B facility, we can batch compound sterile medications for office use under FDA oversight.

Yes. We perform phase-appropriate method development and validation (Phase I, II, III, and commercial) in compliance with ICH and FDA standards. We provide full regulatory packages including protocols, validation reports, raw data summaries, and stability documentation.
Routine analytical tests are typically completed within a few business days. Sterility testing begins immediately after production and may use rapid methods when applicable. Exact timelines depend on product complexity and are confirmed in advance during project planning.
A: The process is simple: 1. Initial Contact – Reach out via our website or email with your request. 2. Proposal – We’ll provide a detailed quote or scope of work. 3. Sample Submission – Send your materials with our guidance. 4. Execution – We perform the work and provide full results and documentation. Our team will support you at every stage—from kickoff to final delivery.