WHO GMP Certified API Supplier for Chile — Aarise Pharmaceuticals India

Aarise Pharmaceuticals is a WHO GMP certified API supplier in Haridwar, India, exporting 100+ pharmacopeial grade APIs to pharmaceutical buyers in Chile. Our WHO GMP certificate is issued by CDSCO India and accepted by ISP (Instituto de Salud Publica de Chile) for API import approval.

Our WHO GMP Certification

• Issuing Authority: CDSCO (Central Drugs Standard Control Organisation, India)
• Manufacturing Site: SIDCUL Industrial Area, Haridwar, Uttarakhand, India
• Scope: API manufacturing across all therapeutic categories
• Additional Certification: ISO 9001:2015, NABL-accredited QC Laboratory
• Accepted by: ISP, FDA, EMA, ANVISA, COFEPRIS, INVIMA, MFDS, SAHPRA, TGA

Why Chile Buyers Require WHO GMP Certified APIs

ISP (Instituto de Salud Publica de Chile) requires: ISP import authorisation, WHO GMP certificate, Spanish-language product dossier, Chilean importer required. A current WHO GMP certificate from the Indian manufacturer is a core document for ISP import clearance. Without it, customs clearance for pharmaceutical APIs in Chile will be rejected.

WHO GMP Certified APIs for Chile

All APIs from Aarise Pharmaceuticals are manufactured under WHO GMP conditions and supplied with a current GMP certificate. Key molecules include: Metformin HCl (USP/BP/IP), Dexamethasone (USP/BP/IP), Prednisolone (USP/BP/IP), Atorvastatin (USP/BP), Amoxicillin (USP/BP/IP), Ciprofloxacin (USP/BP), Testosterone Enanthate (USP/BP), Progesterone (USP/BP/IP), Omeprazole (USP/BP), Ibuprofen (USP/BP/IP), and 90+ more.

Documentation Package for Chile

• WHO GMP Certificate (current, CDSCO India)
• Batch Certificate of Analysis (COA)
• MSDS / SDS (GHS format)
• COPP (Certificate of Pharmaceutical Product)
• DMF support for ISP
• Certificate of Origin
• Stability data and shelf-life documentation

To receive our WHO GMP certificate and a product list for Chile, contact Aarise Pharmaceuticals at +91 9899783330. We send all pre-qualification documents within 24 hours.

Frequently Asked Questions

Is WHO GMP certification accepted for API imports in Chile?

Yes. ISP (Instituto de Salud Publica de Chile) accepts WHO GMP certification from Indian API manufacturers as a basis for import approval. ISP import authorisation, WHO GMP certificate, Spanish-language product dossier, Chilean importer required. Aarise Pharmaceuticals holds a current WHO GMP certificate issued by CDSCO India.

How do I verify a WHO GMP certificate from an Indian API supplier?

To verify a WHO GMP certificate from an Indian manufacturer: 1) Check the issuing authority — must be CDSCO (Central Drugs Standard Control Organisation, India). 2) Verify the certificate is current and covers the specific manufacturing site. 3) Confirm the scope covers the APIs you are purchasing. Aarise Pharmaceuticals provides GMP certificate copies and can facilitate verification through CDSCO records.

What WHO GMP certified APIs does Aarise Pharmaceuticals supply to Chile?

Aarise Pharmaceuticals supplies 100+ WHO GMP certified APIs to Chile including: Metformin HCl, Dexamethasone, Prednisolone, Atorvastatin, Amoxicillin, Ciprofloxacin, Azithromycin, Testosterone Enanthate, Progesterone, Omeprazole, Ibuprofen, Diclofenac, and more. All molecules available with full ISP-compliant documentation.

What documentation comes with WHO GMP certified APIs for Chile?

Every WHO GMP certified API shipment to Chile from Aarise includes: WHO GMP Certificate (current), batch COA per ISP specification, MSDS/SDS in GHS format, COPP, DMF support for ISP, Certificate of Origin, and stability data.

How long is a WHO GMP certificate valid for API supply to Chile?

WHO GMP certificates issued by CDSCO India are typically valid for 3 years. Aarise Pharmaceuticals maintains a current WHO GMP certificate and provides copies with every export. Contact us to receive the current certificate and validity date for your ISP records.