Morepen Laboratories
- PharmAssess™ GMP Audit
About Morepen Laboratories Ltd
Established in the year 1984, Morepen Laboratories is a fast growing Pharmaceutical company.
Today Morepen has steadily grown from a Single product company to a Multi activity company with a global vision and satisfied customers in over 50 countries. It has resources of international standing; USFDA approved manufacturing facility for API at Masulkhana (Himachal Pradesh), adhering to the most stringent standards of quality excellence. In addition to this state-of-the-art finished dosage and API plants at Parwanoo and Baddi (Himachal Pradesh) have the latest cGMP guidelines, and their Quality Systems, Technical Product Information and Documentation processes etc., are in perfect line to meet the regulatory requirements for Exports to various countries.
Morepen has a progressive lineage of manufacturing high quality Generic drugs and Pharmaceutical formulations backed by a strong R&D, Regulatory and global marketing team. The big thrust of Morepen’s strategy is, focused on creating a new category in the Indian International pharmaceutical market vis a vis, Pharma Contract Manufacturing. Morepen aims to provide sufficient visibility to its products and direct its business portfolio to the high value DMFs and ANDA driven International Export Business. Apart from leveraging its traditional strength in APIs, the Company is now concentrating on finished formulations in both regulated and non-regulated markets.
About the Audit
The audit of the Morepen Laboratories Limited site was performed on 11 - 12 October 2007. The Report includes photographs and is 40 pages long, excluding appendices. Including appendices the Report is 97 pages long.
The Audit Report provides information on the site facilities and covers a wide range of materials, including; Loratadine, Desloratadine, Atorvastatin Calcium (Amorphous), Atorvastatin Calcium (Form VI), Atorvastatin Calcium (Form I), Montelukast Sodium, Pioglitazone HCI, Fexofenadine HCI, Fluvastatin Sodium, Cisapride, Zafirlukast Crystalline, Sultamicillin Tosylate, Sutamicillin Base, Paracetamol, Divalproex Sodium, Carvedilol, Simvastatin, Bupropion HCI, Venlafaxine HCI, Warfarin Sodium IPA Clathrate, Ramipril, Lamotrigine.
How to Purchase an Audit
Once you have decided which PharmAssess™ audit report(s) you require, purchasing a report is very simple:
- A quotation will be sent to you for the purchase of the Audit Report(s) you require.
- Rephine obtains auditee's approval for sale of the report.
- Once approval of the Quotation is received we will dispatch the Audit Report, in CD format accompanied by an Invoice.
- On receipt of payment the password to access the report is immediately issued
Purchase this Audit »
Ad-Hoc Audit Requirements
Please note that if there are other audits that you require, which are not in the PharmAssess Section of this website, please contact us to discuss your audit requirements, which we can undertake on your behalf.
Rephine has an ongoing programme of audits which is being constantly updated. If an audit you require is not on the list of those available, please contact the Rephine office to establish whether it is in the programme to be done or how it can be fitted in to the programme.
Commissioned GMP Auditing »
Further Information
If you require further information about the PharmAssess™ services offered by Rephine, or you would like to purchase an Audit Report, please contact us by email at enquiries@rephine.com or telephone 0044 1763 853135