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WHO GMP Certified API Manufacturer India — Certificate & Export Documentation | Aarise
Aarise Pharmaceuticals holds WHO GMP certification for its manufacturing facility in Haridwar, India. We supply WHO GMP certified APIs and finished pharmaceutical formulations to buyers in 18 countries — USA, Germany, Brazil, Mexico, Colombia, South Korea, and more.
Need WHO GMP documentation for your regulatory submission?
We provide GMP certificate, COA, MSDS, stability data, and market-specific regulatory support.
+91 9899783330 | Request Documentation →
Our WHO GMP Certification — At a Glance
| Detail | Information |
|---|---|
| Certification | WHO GMP Certified Manufacturing Facility |
| Location | Haridwar, Uttarakhand, India |
| Issued by | State Licensing Authority, Uttarakhand |
| Scope | API manufacturing + finished pharmaceutical formulations |
| QC Lab | NABL-accredited in-house laboratory |
| Capacity | 50+ crore tablets annually |
Request our WHO GMP Certificate →
What is WHO GMP Certification?
WHO GMP (Good Manufacturing Practice) guidelines, established by the World Health Organization, provide the framework for manufacturing, testing, and quality assurance to ensure pharmaceutical products are safe, effective, and of consistent quality.
For international pharmaceutical buyers, a WHO GMP certified supplier means:
- Products manufactured under validated, documented processes
- Batch-specific quality testing with COA issued per lot
- Traceability from raw material to finished product
- Compliance with ICH Q7 (for APIs) and relevant pharmacopeias
When importing APIs into regulated markets — USA (FDA), Europe (EMA), Germany (BfArM), Brazil (ANVISA), Mexico (COFEPRIS) — the supplying manufacturer must hold valid WHO GMP certification. Without it, customs clearance can be blocked and regulatory submissions rejected.
Importing from Aarise — Documentation by Country
Colombia Colombia (INVIMA)
INVIMA requires WHO GMP certification from all API and pharmaceutical suppliers. Aarise provides:
- WHO GMP Certificate (current, valid)
- Certificate of Analysis (COA) — batch-specific
- MSDS (Material Safety Data Sheet)
- Certificate of Origin
- Stability data and shelf-life documentation
- Technical dossier on request
Colombian buyers: We have experience exporting to Colombia and understand INVIMA documentation requirements. Contact us →
South Korea South Korea (MFDS)
The Ministry of Food and Drug Safety (MFDS) requires GMP compliance documentation for all imported pharmaceutical ingredients. Aarise provides:
- WHO GMP Certificate
- COA with full analytical data
- MSDS
- Batch manufacturing records on request
- Regulatory support for MFDS submissions
South Korean buyers: We supply to South Korean pharma importers and provide all MFDS-required documentation. Contact us →
Mexico Mexico (COFEPRIS)
COFEPRIS requires GMP certification from all pharmaceutical manufacturers supplying to Mexico. Aarise provides:
- WHO GMP Certificate
- COA and MSDS in Spanish-compatible format
- Stability data
- Certificate of Pharmaceutical Product (COPP) on request
- Spanish labelling support
Mexican buyers: We export to Mexico and understand COFEPRIS requirements. Contact us →
USA USA (FDA / cGMP)
For US market entry, Aarise provides:
- WHO GMP Certificate (accepted as cGMP equivalent for many submissions)
- Drug Master File (DMF) support for ANDA/NDA
- FDA-format COA and stability data
- cGMP compliance documentation
Germany / EU Germany / EU (EMA / BfArM)
- WHO GMP Certificate
- EDQM CEP support where applicable
- EU-format COA and MSDS
- Regulatory dossier support
Brazil Brazil (ANVISA)
- WHO GMP Certificate
- ANVISA-format documentation
- IFA supplier documentation
- Portuguese labelling support
WHO GMP Requirements — What We Comply With
Facility Standards
- HVAC systems with environmental monitoring
- Cleanroom classifications as per product requirements
- Validated water treatment systems (purified water, WFI)
- Pest control and contamination prevention programs
Equipment
- Qualification protocols (IQ/OQ/PQ) for all critical equipment
- Calibration programs with documented records
- Preventive maintenance schedules
Documentation System
- Standard Operating Procedures (SOPs) for all processes
- Batch manufacturing records with full traceability
- Stability studies per ICH guidelines
- Deviation management and CAPA system
Quality Control Laboratory
- NABL-accredited in-house QC laboratory
- HPLC, UV spectrophotometry, dissolution testing
- Method validation documentation
- Retain samples for all batches
How to Verify a WHO GMP Certificate
Before sourcing from any Indian manufacturer, verify:
Request Aarise’s WHO GMP Certificate →
Frequently Asked Questions
Is WHO GMP the same as FDA GMP?
WHO GMP and FDA cGMP are based on the same principles but have some differences in documentation requirements. WHO GMP is accepted in most regulated markets outside the USA. For FDA submissions, additional documentation is required — we provide this support.
Do you have FDA registration?
Contact us for current regulatory status and documentation. We provide full support for buyers submitting to FDA.
Can I get a copy of your GMP certificate before placing an order?
Yes. Request documentation via our contact form and we will provide the current certificate along with facility details within 24 hours.
How often is WHO GMP certification renewed?
WHO GMP certificates are typically valid for 1–3 years and renewed through re-inspection. Our facility maintains continuous compliance.
Do you provide facility audit support?
Yes. We support virtual audits and in-person facility visits for international buyers. Contact us to schedule.
Request WHO GMP Documentation
+91 9899783330 | +91 9289410333
Aarise Pharmaceuticals | WHO GMP Certified | Haridwar, India | aarisepharma.com