Thursday, October 02, 2014
Audit Reports Minimize

The following audit reports are available for sale to both Rx-360 members and non-members.  

Rx-360 audit reports are available for licensing to both members and non-members of Rx-360.  Prior to licensing, permission to license the report is requested from the supplier through an addendum to the original Confidentiality Agreement (CDA).  Once this is obtained members are invoiced $2500 for the report and may access it through auditsPLUS.  Non-members are asked to sign the Rx-360 Licensing Agreement and pay a $5000 licensing fee.  The report, CAPA plan and auditor CV’s are then provided via email.

Questions regarding report licensing or to purchase one of these reports please contact Ms. Dede Godstrey at dede.godstrey@dbr.com.

 

Region Material Company Location Audit Date Materials
Europe Raw Materials Sigma-Aldrich Holding Ltd (Switzerland) Buch, Switzerland  TBD Quality Systems Audit
USA Raw Materials Sigma-Aldrich Manufacturing LLC St. Louis, MO TBD Quality Systems Audit
Europe Basic Chemical/Raw Materials Soffieria Bertolini S.P.A. Candiolo, Italy TBD ampoules, vials and cartiridges
Israel API ABIC Netanya, Israel Nov-14 TBD
Europe Raw Materials Sigma-Aldrich Company Ltd Irvine, Scotland  United Kingdom Nov-14 Quality Systems Audit
Europe API DSM Nutritional Products Village Neuf, France Oct-14 TBD
Europe API DSM Nutritional Products Sisseln, Switzerland  Oct-14 TBD
USA Raw Materials SAFC Cleveland Cleveland, OH Oct-14 Quality Systems Audit
Asia API Lonza Guangzhou Nansha Aug-14 Niacinamide USP 
USA Raw Materials SAFC Lenexa, KS Jul-14 Quality Systems Audit
USA Excipient GEO Specialty Chemicals Deer Park, TX Jun-14 TBD
Europe API Bayer Bergkamen and Berlin Charlottenburg May-14 TBD
Asia API Hovione Macau, China May-14 Various materials
USA API BASF Bishop, Texas Apr-14 Ibuprofen
USA Excipients Clariant Burgkirchen Germany  Mar-14 TBD
Europe Excipients Hovione Cork, Ireland Mar-14 Various materials
USA Packaging West Pharml Services, Inc. Jersey Shore, PA Feb-14 1. Stoppers, sterile, bio-safe bagged
2. Plunger tips
USA API BASF Peabody, MA Jan-14 GDP
Europe API BASF PharmaChemikalien GmbH Minden, Germany Jan-14 1. Pseudoephedrin Hydrochloride
2. Tretinoin
3. Caffeine
4. Phenylephrine Hydrochloride
5. Oxymethazolin HCL        
6. Tretinoin  
7. Buprenorphine T2712 
8. Ibuprofen Lysine Salt 
USA Packaging GE Healthcare Westborough, MA Jan-14 ready to use bags, filters, tubing’s, connectors and assemblies
Europe API/Excipients Hovione Loures, Portugal Jan-14 Various materials
Europe API MOEHS IBERICA S.L. Barcelona, Spain Jan-14 1. Lidocaine chlorhydrate
2. mantadine hydrochloride
3. Metoprolol tartrate
4. Metoprolol succinate
5. Lidocain NAC
6. Lidocaine HCL
7. Niclosamide
Europe Excipients Merck  Mollet des Valles, Spain Nov-13 1. 1.08386.9025 Tris amino methane
2. 1.08421.9025 Titriplex III
Europe Packaging Lajovic Tuba Slovenia Oct-13 Tubing
USA Packaging Amcor Flexibles Shelbyville,  KY Oct-13 Packaging
USA Packaging Constantia Blythewood, SC Sep-13 Flexible Packaging
USA Packaging Gerresheimer Glass Morgantown, NC Sep-13 Vials
India API Sun Pharmaceuticals Gujarat, India Sep-13 1. Budesonide
2. Budesonide Caps
3. Flucticasone Proportionate Micronised
4. Prednicarbate
USA Excipients W.R. Grace Baltimore, MD Sep-13 Cocarboxylase Chloride (Merck mat. no. 5.00112)
Potassium Iodide (Merck mat. no. 1.05040)
Praziquantel (Merck mat. no. 5.00022)
Sodium Perchlorate (Merck mat. no. 1.06567)
Urea (Merck mat. no. 1.08432)
Europe API Merck KGaA Darmstadt, Germany Aug-13 Various API
Europe Packaging Datwyler Ittersbach, Germany Aug-13 Stoppers
USA Packaging Berry Plastics Sarasota , FL Aug-13 1. Stoppers
2. Closures
Europe Excipients Merck KGaA Darmstadt, Germany Aug-13 N-Butylalcohol (1-Butanol) EMPROVE® exp 1.00988
Calcium chloride dihydrate 1.60515
Butylhydroxytoluene 8.17074
Citric acid anhydrous EMPROVE® exp 1.00241
Copper sulfate anhydrous EMPROVE® exp 1.02792
Copper sulfate pentahydrate EMPROVE® exp 1.02788
Ethanol absolute EMPROVE® exp 1.00986
Fructose EMPROVE® exp 1.05321
Magnesium oxide heavy EMPROVE® exp 1.05867
Manganese sulfate hydrate EMPROVE® exp 1.05999
Phosphoric Acid EMPROVE® bio 1.00250
Di-Potassium hydrogenphosphate EMPROVE® exp 1.05101
Potassium dihydrogenphosphate EMPROVE® exp 1.04871
Potassium hydroxide pellets EMPROVE® exp 1.05032
Sodium hydroxide pellets EMPROVE® exp 1.06482
Sodium metabisulfite EMPROVE® exp 1.06357
Sodium chloride EMPROVE® exp 1.06400
Sodium hydrogen carbonate EMPROVE® exp 1.06323
Sorbitol Parteck SI 400 EMPROVE® exp 1.03140
Zinc sulfate monohydrate EMPROVE® exp 1.08882
Zinc sulfate heptahydrate EMPROVE® exp 1.08881
United States Basic Chemicals / Raw Materials SAFC Biosciences (Broadway) St. Louis, MO Aug-13 1. 1% Simethicone
2. Selenious Acid
3. L-Tyrosine
4. Additional Materials
Asia API Beecham Singapore Jul-13 Amoxicillan
United States Excipients Foremost Farms Rothschild, WI Jun-13 1. Lactose (Hydrous) Ph Eur (Fast Flow)
2. Lactose Monohydrate Modified NF, EP, JP 316 Mesh FF
3. Lactose Monohydrate,NF (316 Fast-Flo); Lactose
4. Lactose Monohydrate; Lactose Fast-Flo
5. Calcium Phosphate
6. Calcium Phosphate Tribasic
7. Dibasic Calcium Phosphate
Europe API GSK Services, Ltd.. West Sussex, UK Jun-13 Mupirocin
Asia API Plantex Teva Israel Israel Jun-13 Allopurinol
Asia API Lonza - Guangzhou Haizhu District, CN-Guangzhou, China May-13 Niacinamide USP
Europe API Bidachem Fornovo S. Giovanni, Italy Apr-13 1. Bisacodyl
2. Bromhexine Hydrochloride
3. Crotamiton
4. Dropropizine
5. Ketoprofen
USA Excipient Croda Mill Hall, PA Apr-13 1. Sorbitan Monoleate
2. Super Refined Cottonseed
3. Super Refined Olive Oil, Tween 80,
4. Polyoxyl 20 Cetostearyl Ether (Cetomacrogol 1000 BP) NF
5. Crill 4NF (Sorbitan Monoleate NF)
6. Super Refined PEG 400 NF (Polyethylene Glycol 400)
7. Cetyl Alcohol NF (Crodacol C95 Pastilles)
8. Cetostearyl Alcohol NF
9. Emulsifying Wax NF  (Polawax Pastilles)
10. Stearyl Alcohol NF (Crodacol S95 Pastilles)
11. Polysorbate 80, Tween 80
Asia API Teva Beer Sheva, Israel Feb-13 Leflunomide, Mirtazapin, Pregabalin
Europe API/Excipients DSM Dalry Drakemyre, Dalry, Aryshire, U.K. Jan-13 1. Ascorbic Acid Crystalline
2. Ascorbic Acid Fine Powder
3. Ascorbic Acid Ultra Fine Powder
4. Ascorbic Acid, Fine GranularCoated
5. Ascorbic Acid, Type FC
6. Coated Ascorbic Acid, Type EC
7. Sodium Ascorbate, Crystalline
8. D-Panthenol
9. Calcium D-Pantothenate  
Europe API/Excipients DSM Nutritional Products Grenzach-Wylen, Germany Jan-13 1. Thiamine Hydrochloride (code: 0413038)
2. Thiamine Mononitrate (code: 0418943)
3. Riboflavin universal (code: 0470406)
4. Riboflavin tablet grade (code: 0470295
5. Pyridoxine Hydrochloride (code: 0411604)
Europe API Pharmacosmos A/S Holbaek, Denmark Jan-13 Iron Dextran
Europe Primary Packaging ABC-IMPEX srl  Odorheiu Secuiesc Romania Nov-12 Aluminium foils, leaflets and cartons
Europe Primary Packaging Nipro Munnerstadt, Germany Nov-12 1. Glass Ampules
2. Glass Viles
3. Zomig Glass Vial
United States Basic Chemical/Raw Material SAFC Cleveland, OH Nov-12 1. Tris, UP
2. Tromethamine, USP
3. Tromethamine, USP,BP, EP
Canada Excipients Innophos Port Maitland, Ontario Oct-12 1. Tetrasodium Pyrophosphate
2. Sodium Pyrophosphate
3. Tetrasodium Phosphate
Europe Primary Packaging Schott Pharmaceutical (ACM) Mulheim, Germany Sep-12 50 cc vials
Europe APIs BASF Pharmachemikalien GmbH Minden, Germany Sep-12 1. Theophylline Anhydrous
2. Caffeine anhydrous
3. Ephedrine
4. Pseudoephedrine
5. Oxymetazoline
6. Dopamine
7. Theophylline
Europe Primary Packaging Amcor Flexibles Singen, Germany Aug-12 1. Aluminium Foil
2. Sachet Foil
3. Formable Web Material
United States Excipients Biospectra (Excipient Mfg Location) Stroudsburg, PA Aug-12 Tromethamine USP, Urea, Tris, Tris HCl, GHCl
United States Primary Packaging Chesapeake Pharmaceutical Packaging Raleigh, NC Aug-12 Printed Materials
United States Basic Chemica/Raw Material Sartorius Stedim Yauco, Puerto Rico Aug-12 Bioprocess Bags
Europe Printed Components Packetis Chazelles, France Jul-12 Boxes
Europe APIs, Excipients Chemische Fabrik Budenheim Budenheim, Germany Jul-12 API’S
1. Calcium phosphate
2.Sodium Phosphate
EXCIPIENTS

1. Calcium hydrogenphosphate
2. Magnesium hydrogenphosphate
3. Calcium Hydrogen Phosphate Dihydrate
United States APIs International Specialty Products (ISP) Calvert City, KY Jul-12 1. Povidone (ISP Plasdone K-90 & Plasdone K-29/32)
2. Crospovidone (ISP Polyplasdone XL & Polyplasdone XL-10)
3. Povidone Iodine (ISP PVP Iodine),
United States Excipients Avantor Performance Materials Paris, Kentucky Jun-12 1. Calcium Chloride Dihydrate, granulate (mat. 4616)
2. Edetate Disodium Dihydrate (mat. 7727, mat. 1395)
3. Hydrochloric Acid, diluted (mat. 2608) ,Hydrochloric Acid, 6N (mat. 0327)
4. Magnesium Chloride 6*Hydrate, crystal (mat. 2449)
5. Mannitol powder (mat. 2553)
6. Polysorbate 80 (mat. 4117)
7. Potassium Chloride, granular (mat. 6838)
8. Potassium Chloride, crystal (mat. 6845)
9. Potassium Phosphate Monobasic, crystal (mat. 3248, mat. 7096)
10. Sodium Phosphate Monobasic, Monohydr., granular (mat. 7868)
11. Sodium Chloride, granular (mat. 3627, mat. 7713)
12. Sodium Citrate Dihydrate, crystal (mat. 0734, mat. 7773)
13. Sodium Hydroxide, 5N Solution (mat. 0895)
14. Sodium Phosphate Dibasic 7*Hydrate (mat. 3803, mat. 3816) 
United States Primary Packaging Barnhardt Manufacturing Co. Carolina Absorbent Cotton Pomfret Center, CT Jun-12 Pharmaceutical: Coil Cotton, Rayon, Polyester
United States Basic Chemicals / Raw Materials West Pharml Services, Inc. Lititz, PA May-12 5 mL 13mm diameter glass vials
United States Excipients, Basic Chemicals / Raw Materials Morton Salt (Excipient Mfg Location) Rittman, OH May-12 Sodium Chloride, USP
United States Excipients Capsugel Greenwood, SC Mar-12 1. Empty hard gelatin capsules, type Coni-Snap, in different sizes and colors with/without imprints
2. HPMC empty hard capsules, type VcapsPlus, in different sizes and colors with/without imprints
3. Empty hard gelatin capsules, type DB-caps, different sizes and colors with/without imprints
4. Empty hard gelatin capsules, type Licaps, different sizes and colors with/without imprints
5. Empty hard gelatin capsules, 100% bovine, type Coni-Snap
6. “Halal” Empty hard gelatin capsules, type DB caps
Europe Chromatography Resins GE Healthcare Uppsala, Sweden Oct-11 1. Q Sepharose Fast Flow
2. MabSelect 
Europe API GSK Scotland, UK Sep-11 1. Potassium Clavulanate 
United States Excipient ISP Corp. Texas City, TX Sep-11 1. Polyplasdone, XL-10
2. Polyplasdone XL
3. Plasdone K-29/32
Europe API Labochim Milan, Italy Sep-11 1. Diclofenac Sodium
2. Propentofylline
Europe Basic Chemical/Raw Material Sigma-Aldrich Buch, Switzerland  Aug-11 1. Benzenesulfonic acid
2. N-Acetyl-DL-tryptophan
United States API AMPAC Fine Chemicals Rancho Cordova, CA Jul-11 GMP Audit
Asia API Hovione Macau, China Jul-11 Various materials
Europe API DSM Nutritional Products Sisseln and Van Neuf, Switzerland Jun-11 1. DL-ALPHA TOCOPHEROL
2. PALMITATO VITAMINA A (P 1.7)
3. DL-Alpha-Tocopheryl acetate
4. Cholecalciferol E.P. (Vit.D3)
5. BETA-CAROTENE 1%CWS

 

  

 

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