Quality & compliance
A GMP API manufacturer your auditor can close the file on
Certifications matter to a pharma buyer only in terms of what they let you do. Here is each one we hold, what it evidences, and the documentation you can ask us for today.
Certifications we hold
Each certificate below is held in the name of Apex Pharma at our Saykha GIDC plant. Click any certificate to view the scan.
Bulk Drugs (APIs) under Revised Schedule M, Drugs & Cosmetics Act 1940; drug licences Form 25 & 28.
- Issuer
- Food & Drugs Control Administration, Gujarat State
- Cert no.
- S-GMP & GLP/24044900
- Valid
- 05 Apr 2024 – 04 Apr 2026
Your audit finds a batch record for every kilogram, not a reconstruction after the fact.
Own testing laboratory complying with Good Laboratory Practices, Schedule L1, Drugs & Cosmetics Rules 1945.
- Issuer
- Food & Drugs Control Administration, Gujarat State
- Cert no.
- S-GMP & GLP/24044900
- Valid
- 05 Apr 2024 – 04 Apr 2026
The data on your CoA comes from a laboratory held to a defined standard, not an unaudited bench.
Scope: Manufacturer, Exporter and Supplier of Pharmaceutical API and Intermediates.
- Issuer
- ICV Assessments Pvt. Ltd. (IAF / EGAC accredited)
- Cert no.
- IN/62112237/9696
- Valid
- 04 Mar 2024 – 03 Mar 2027
Evidence that the quality process survives staff changes and volume growth.
Zero Defect Zero Effect scheme; Udyam registration UDYAM-GJ-06-0009411.
- Issuer
- Ministry of Micro, Small & Medium Enterprises, Government of India
- Cert no.
- 09072024_307326
- Valid
- 09 Jul 2024 – 08 Jul 2027
An independent, government-backed signal of a disciplined manufacturing operation.
Documentation available
Ask once, receive the set
Applies across all eight APIs — we do not repeat the documentation story on every product page, because the answer does not change by molecule.
Issued batch-wise as standard with every despatch — never on request only.
DMF support and open-part documentation available on request for regulated filings.
Available for applicable molecules; confirmed per product and destination market.
Current MSDS supplied with quotation for handling and transport clearance.
Product specification and method of analysis against the applicable monograph.
Analytical data package shared under NDA where your filing requires it.
Our quality process
Four control points between raw material and your drum
Raw materials sampled, identified and released before they reach the block.
Defined control points during the campaign, recorded against the batch record.
Full analysis against the monograph; QC releases before packing, not after.
Control samples retained so any query months later can be answered against the same batch.
