Alembic Final
- PharmAssess™ GMP Audit
About Alembic Limited
API remains to be significant operations for Alembic Limited.
The fermentation based APIs are manufactured at its main manufacturing facility exceeding 3 million sq.mt. This ISO-9002 & ISO14001
accredited facility also houses the central R& D (microbial & Chemical) set-up and Quality Assurance activity.
Alembic has an exclusive facility for manufacturing synthetic APIs, consisting of imdependent
manufacturing blocks for Macrolides, NSAIDs and other drugs. API manufacturing facility at panelav has successfully under gone inspection of USFDA and EDQM.
About the Audit
The Audit Report provides information on the site facilities and covers a wide range of materials, including; Furosemide BP,
Erthomycin Ph. Eur/BP, Venlafaxine Hydochloride IH, Loratadine USP, Metformin Hydrochloride BP, Topiramate IH, Perindopril
Erbumine Ph. Eur, Venlafaxine Hydochloride (Form B) IH, Venlafaxine Hydochloride (Form C) IH, Diclofenac Sodium Ph. Eur BP,
Leflunomide IH, Losartan Potassium IH, Atenolol Ph. Eur., Rivastigmine Hydrogen Tartrate IH, Pramipexole Dihydrochloride
Monohydrate IH, Lansoprazole USP, Famotidine USP, Verapamil Hydrpchloride USP, Lithium Carbonate USP, Metronidazole USP,
Gliclazide BP, Pioglitazone Hydrochloride IH, Fluoxetine Hydrochloride USP, Hydrochlorothiazide Ph. Eur., Irbesartan USP,
Metformin Hydrpchloride Ph. Eur. Trimethorpin BP, Sulfamethoxazole BP, Meprobamate USP, Theophylline Anhydrous USP.
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- 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
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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.
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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