Official Regulatory Verification Repository

Certifications & Regulatory Approvals

Highsea Pharmaceutica adheres to rigorous regulatory standards. Inspect authenticated DRAP registration letters, Certificates of Analysis (COA), CE marks, and sole agency authorizations in our protected viewer.

Anaesthesiology Regulatory Documentation

Registration letters, COPP embassy verifications, and batch COAs for Aislar (Isoflurane) & Seaflurane (Sevoflurane).

8 Documents
AnaesthesiologyDRAP Letter

Aislar (Isoflurane USP) DRAP Registration Letter

Drug Regulatory Authority of Pakistan (DRAP)

Official enlistment and registration approval for Aislar (Isoflurane, USP 100mL) inhalation anaesthetic in Pakistan. Registration No: 114286.

AnaesthesiologyDRAP Letter

Seaflurane (Sevoflurane USP) DRAP Registration Letter

Drug Regulatory Authority of Pakistan (DRAP)

Official drug registration letter authorizing importation and hospital distribution of Seaflurane in Pakistan. Registration No: 122439.

AnaesthesiologyDRAP Letter

Seaflurane Brand Name Corrected Approval Letter

Ministry of National Health Services / DRAP

Regulatory confirmation letter regarding official proprietary brand name correction for Seaflurane (Sevoflurane USP).

AnaesthesiologyEmbassy Notification

Certificate of Pharmaceutical Product (COPP) - Isoflurane

Embassy of Pakistan / NMPA Health Authorities

WHO-format Certificate of Pharmaceutical Product (COPP) validated by the Embassy of Pakistan for Fujian Highsea Isoflurane.

AnaesthesiologyCOA

Batch Certificate of Analysis (COA) - 24-A (Isoflurane)

Fujian Highsea United Pharmaceutica QA/QC

Finished product laboratory quality release certificate verifying 99.9% purity and USP compliance for Isoflurane batches.

AnaesthesiologyCOA

Batch Certificate of Analysis (COA) - 24-B (Isoflurane)

Fujian Highsea United Pharmaceutica QA/QC

Comprehensive chemical assay and gas chromatography quality report for imported Isoflurane consignments.

AnaesthesiologyCOA

Batch Certificate of Analysis (COA) - 24-C (Isoflurane)

Fujian Highsea United Pharmaceutica QA/QC

Detailed analytical release documentation including volatile impurity testing, moisture limits, and specific gravity.

AnaesthesiologyCOA

Batch Certificate of Analysis (COA) - 24-D (Isoflurane)

Fujian Highsea United Pharmaceutica QA/QC

Quality assurance certificate detailing packaging integrity, halide limits, non-volatile residue, and batch conformance.

Ophthalmology Medical Device Certifications

DRAP registration certificates and European CE technical catalogues for Sidapharm IOLs (SLens) & SHPMC 2%.

3 Documents
OphthalmologyDRAP Letter

Registration of SIDA-Lens (Foldable Acrylic IOL)

DRAP Medical Devices Division

Official DRAP medical device registration and import clearance for Sidapharm SLens Hydrophobic Foldable Intraocular Lenses. Reg No: MDIR-0008123.

OphthalmologyDRAP Letter

Registration of SIDA-HPMC (Hypromellose Solution 2%)

DRAP Medical Devices Division

Regulatory enlistment documentation for Sidapharm SHPMC 2% ophthalmic viscosurgical device (OVD) solutions. Reg No: MDIR-0008124.

OphthalmologyCatalogue & Specs

Sidapharm Complete Ophthalmic Product Catalogue & Specs

Sidapharm Greece (European CE Notified Body)

Official manufacturer technical portfolio detailing foldable IOL dimensions, dioptric powers, OVD viscoelastic properties, and injector specifications.

Corporate Import Licences & ADC Approvals

Manufacturer Sole Agency Agreements, DRAP Medical Devices Import Licences, and ADC statutory clearance letters.

7 Documents
GeneralAgency Certificate

Exclusive Sole Agency Authorization Certificate

Fujian Highsea United Pharmaceutica Co. Ltd.

Formal legal authorization granting Highsea Pharmaceutica exclusive marketing and distribution rights across Pakistan.

GeneralImport Licence

Medical Devices Importer Licence (MD)

Drug Regulatory Authority of Pakistan (DRAP)

Official corporate import licence (ELI-01251) permitting institutional importation of hospital medical devices and surgical consumables.

GeneralDRAP Letter

ADC Approved Enlistment Certificate - Part 1

Appellate / Drug Clearance Committee (DRAP)

Statutory import clearance and registration docket approved under DRAP statutory regulations.

GeneralDRAP Letter

ADC Approved Enlistment Certificate - Part 2

Appellate / Drug Clearance Committee (DRAP)

Official endorsement and clearance document from the DRAP regulatory evaluation committee.

GeneralDRAP Letter

ADC Approved Enlistment Certificate - Part 3

Appellate / Drug Clearance Committee (DRAP)

Regulatory validation documentation for institutional drug importation and customs release.

GeneralDRAP Letter

ADC Approved Enlistment Certificate - Part 5

Appellate / Drug Clearance Committee (DRAP)

Technical evaluation endorsement and commercial consignment clearance certificate.

GeneralDRAP Letter

ADC Approved Enlistment Certificate - Part 6

Appellate / Drug Clearance Committee (DRAP)

Final statutory registration and clearance document for institutional hospital delivery.