99% Hydrocortisone API Of GMP Manufacturer

1. What are the primary therapeutic uses of Hydrocortisone API?
Hydrocortisone, along with our Hydrocortisone Acetate API, is a versatile corticosteroid used to replace natural cortisol in adrenal insufficiency (Addison’s disease). Its potent anti-inflammatory properties make it effective in treating many conditions, including skin disorders (eczema, psoriasis, contact dermatitis), allergic reactions, and ulcerative colitis, as well as in immunosuppression.

2. Is your manufacturing facility cGMP compliant and audited?
Yes, our manufacturing facility is fully compliant with current Good Manufacturing Practices (cGMP). We are regularly audited and have been successfully approved by several international regulatory bodies (US FDA, EDQM/TGA). We are prepared to support customers with official regulatory audits.

3. What regulatory documentation do you provide to support our filings?
We provide a complete dossier to streamline your regulatory submissions, which includes:

• Certificate of Analysis (COA) for every batch.

• Drug Master File (DMF) for the US FDA and/or Active Substance Master File (ASMF/CEP) for the EMA.

• Stability Data (accelerated and long-term).

• Material Safety Data Sheet (MSDS).

• A comprehensive Regulatory Support Package.

4. Can you customize the particle size of the Hydrocortisone API?
Yes, we understand that particle size is critical for bioavailability in oral solid dosages and for the texture/efficacy of topical products. We offer standard particle size distributions and can work with you to provide a customized micronization to meet your specific formulation requirements.

5. What is your minimum order quantity (MOQ) and lead time?
Our standard MOQ is 1 kilogram. However, we are committed to supporting businesses of all sizes, including compounding pharmacies that may require smaller quantities. Please get in touch with us to discuss your specific needs. Standard lead times are 3-5 days after your payment is confirmed, with expedited options available for high-volume customers.

6. How does your Hydrocortisone API perform in stability studies?
Our Hydrocortisone API demonstrates excellent stability under recommended storage conditions. Our long-term and accelerated stability studies confirm the product remains within specification over its shelf life. Full stability data is available upon request under a Confidentiality Agreement.

7. What are the recommended storage and handling conditions?
Store in a tight, light-resistant container at a controlled room temperature, typically 15-30°C. Protect from light and moisture. As with all potent APIs, appropriate engineering controls and personal protective equipment (PPE) should be used during handling to minimize operator exposure.

8. Do you offer different grades of Hydrocortisone (e.g., for topical vs. oral use)?
Our standard Hydrocortisone API is highly pure and suitable for all dosage forms, including oral, topical, and parenteral. The primary differentiation often lies in the particle size, which we can customize. The CoA and DMF support its use in all these applications.

9. What is the compatibility of your Hydrocortisone API with common excipients?
Hydrocortisone is generally compatible with standard pharmaceutical excipients used in tablets, creams, and ointments. However, for specific and novel formulations, we recommend conducting compatibility studies as part of your pre-formulation work. Our technical team is available to consult on these matters.

10. We are a compounding pharmacy. Do you provide support for USP <795> and <797> compliance?
Absolutely. We understand the critical quality requirements for pharmaceutical compounding. We provide detailed CoAs with each batch, ensuring you have the necessary data on identity, strength, purity, and quality to meet the standards outlined in USP <795> (Non-Sterile) and <797> (Sterile) for compounded preparations.