Saturday, April 19, 2014
Audit Reports Minimize

The following audit reports are available for sale to both Rx-360 members and non-members.  To purchase one of these reports please contact Ms. Dede Godstrey at dede.godstrey@dbr.com.

 

Region Material Company Location Audit Date Materials
USA Excipient Virginia Dare Brooklyn, NY Nov-13 1. Prosweet LiquidFlavor
2. Various types of Spray Dried Peppermints
3. Spray Dried Spearmint
4. Apricot Flavour
5. Peppermint Flavor
6. Purified Water Flavors
7. Flavor Orange Vanilla
Europe Packaging Lajovic Tuba Slovenia Oct-13 Tubing
USA Packaging Gerresheimer Glass Morgantown, NC Sep-13 Vials
USA Packaging Constantia Blythewood, SC Sep-13 Flexible Packaging
USA Packaging Berry Plastics Sarasota , FL Aug-13 1. Stoppers
2. Closures
Europe Packaging Datwyler Ittersbach, Germany Aug-13 Stoppers
Europe API Merck KGaA Darmstadt, Germany Aug-13 Various API
Europe Excipients Merck KGaA Darmstadt, Germany Aug-13 Various Excipients
USA Excipients W.R. Grace Baltimore, MD Aug-13 Various Excipients
Asia API Beecham Singapore Jul-13 Amoxicillan
Asia API Plantex Teva Israel Israel Jun-13 Allopurinol
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 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 API Croda Mill Hall, PA Apr-13 1. Sorbitan MonoOleate
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), Tween 80
Asia API Teva Beer Sheva, Israel Feb-13 Leflunomide, Mirtazapin, Pregabalin
Europe API Pharmacosmos A/S Holbaek, Denmark Jan-13 Iron Dextran
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/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 Primary Packaging Nipro Munnerstadt, Germany Dec-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
Europe Primary Packaging ABC-IMPEX srl  Odorheiu Secuiesc Romania Nov-12 Aluminium foils, leaflets and cartons
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
United States Basic Chemicals / Raw Materials SAFC Biosciences (Broadway) St. Louis, MO Aug-12 1. 1% Simethicone
2. Selenious Acid
3. L-Tyrosine
4. Additional Materials
Europe Primary Packaging Amcor Flexibles Singen, Germany Aug-12 1. Aluminium Foil
2. Sachet Foil
3. Formable Web Material
United States Basic Chemica/Raw Material Sartorius Stedim Yauco, Puerto Rico Aug-12 Bioprocess Bags
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
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),
Europe Printed Components Packetis Chazelles, France Jul-12 Boxes
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 Excipients, Basic Chemicals / Raw Materials Morton Salt (Excipient Mfg Location) Rittman, OH May-12 Sodium Chloride, USP
United States Basic Chemicals / Raw Materials West Pharml Services, Inc. Lititz, PA May-12 5 mL 13mm diameter glass vials
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 
United States Excipient ISP Corp. Texas City, TX Sep-11 1. Polyplasdone, XL-10
2. Polyplasdone XL
3. Plasdone K-29/32
Europe API GSK Scotland, UK Sep-11 1. Potassium Clavulanate 
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 1. Doxycycline
2. Ivermectin
3. Roxithromycin
Asia Intermediate Aurisco Shanghai, China Jun-11 1. Betamethasone
2. Flumethasone
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
United States Excipient FMC Corporation Newark, DE May-11 1. Croscarmellose Sodium NF
2. Microcrystalline Cellulose NF
3. Aquacoat ECD
United States Basic Chemical/Raw Material Sigma-Aldrich St. Louis, MO May-11 1. T1503, Trizma base 99.9%
2. H3375 HEPES >99.5% 
Asia API Hikal Bangalore, Karnataka India May-11 1. Gabapentin
2. Tripolidine
Asia API CSPC Innovation Pharmaceutical Co. Ltd. Heibei Province, P.R. China May-11 1. Caffeine
Asia Basic Chemical/Raw Material Showa Kako Osaka, Japan May-11 1. 2-mercapto-5-methoxy benzimidazole
Europe API Boehringer-Ingelheim Ingelheim am Rhein, Germany  May-11 1. Digoxin
2. Phenylephrine HC1
3. Adrenaline Tartrate/ Epinephrine Hydrogenotartrate
Europe API Merck KGaA Darmstadt, Germany May-11 1. Methylglucamine (Meglumin)
2. Magnesium Chloride
Europe Excipient BASF Ludwigshafen, Germany May-11 1. Povidone
2. Copovidone
3. Crospovidone 
Europe Excipient Merck KGaA Darmstadt, Germany May-11 1.1.03583 PARTECK SI 150 (SORBITOL)
2. 1.12635 PARTECK DELTA M (MANNITOL)
3. 1.06482 SODIUM HYDROXIDE PELLETS
4. 1.08881 ZINC SULFATE, HEPTAHYDRATE
5. 1.05832 MAGNESIUM CHLORIDE, HEXAHYDRATE CRYSTALS 
United States Excipient Avantor Phillipsburg, NJ Apr-11 1. HCl - Acids Bldg 94 
2. Benzyl Alcohol  - Bldg 97
3. Potassium Phosphate Monobasic - Multi Compendial (RE) - Bldg 110
4. Potassium Nitrate - Large Stainless Steel Train (LSST) 

 

  

 

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