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Rglax Pharma

Quality

Certificates and licences

Everything your audit and regulatory teams will ask for before the first order, with the reference numbers to check them against.

  • Drug Manufacturing Licence

    Drugs Controller, Himachal Pradesh

    NNZ/23/238

    Licence held against our works at Plot No. 30, Industrial Area Tahliwal. It covers the manufacture of the coating materials, polymers and resins listed on this site.

    Copy on request

  • WHO-GMP compliance

    Assessed against WHO Good Manufacturing Practice

    Our unit is operated as a WHO-GMP compliance unit. Manufacturing, cleaning, documentation and release practices follow the same framework your own audit team will be working from.

    Copy on request

  • GST registration

    Government of India

    02AICPN9961B3ZF

    Registered in Himachal Pradesh. Quoted on every invoice.

    Copy on request

  • U.S. Drug Master File

    U.S. Food and Drug Administration

    Applied. Once filed, the DMF supports customer filings that reference our coating materials, so your regulatory team can cite the file rather than duplicating our data.

    Copy on request

Quality and documentation

Yes. We accommodate customer audits of the Tahliwal works. Write to us with what your quality team needs to see and we will arrange it.

Once the file is issued. The U.S. Drug Master File is applied for, and when it is in place your regulatory team can cite the file rather than duplicating our data in your own submission.

The technical and regulatory documentation your filings need. Tell us what your quality team requires at the enquiry stage so it ships with the material rather than being chased afterwards.

What compliance looks like on the floor

A certificate is a document. What it describes is a segregated sampling area, a quarantined reject store and a laboratory that tests every batch before release. Those rooms are photographed on our about page, because they are the part of a GMP claim you can actually check.

Audits and documentation

We supply the technical and regulatory documentation your filings need, and we accommodate customer audits of the Tahliwal works. Write to rglaxpharma@gmail.com with what your quality team needs, or start from the contact page.

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