Form RDS

Release Determination Statement (RDS-)

Production Lot: Release Determination Statement Submission
Manufacturer Information
Manufacturer (FDA-FEI#)*
Check All Manufacturing Functions That Apply*

Measured/Compounded: Location where ingredients are measured, weighed, mixed and compounded.Sterilization: Location where product is sterilized.Vaccines: Location where vaccine is produced.Packaging: Location where intermediate containers will be fixed and labeled. (Primary Packaging and Serialization)Serialization: Location where barcode and DSCSA serialization occurs.Packing: Location where products will be packed and prepared for shipment.Print Components: Location where Print Components are prepared and printed.
Manufacturer POC Name*

First NameLast Name
Manufacturer POC Email*
Product Information
GENERIC NAME*
NDC11*
STRENGTH*
STRENGTH UNIT*
DOSAGE FORM*
PACKAGE TYPE*
Production Batch/Lot Information
LOT NUMBER*
LOT QUANTITY*
BATCH RECORD NUMBER (IF DIFFERENT)
MANUFACTURING DATE*

MonthDayYear
Date
Hour MinutesAM/PM Option
EXPIRATION DATE*

MonthDayYear
If N/A enter the same Manufacturing Date
Additional Information
File Submissions
BATCH RECORD*

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CERTIFICATE OF ANALYSIS (COA)*

Cancelof
OTHER

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Signature

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Acella Pharmaceuticals, LLC FEI:(3006691461) 1880 McFarland Pkwy Ste 110, Alpharetta, Georgia (GA) 30005, United States (USA)
American Injectables, Inc. FEI:(3017511577) 15261 Telcom Drive, Brooksville, Florida (FL) 34604, United States (USA)
Crown Laboratories FEI:(1019820) 349 Lafe Cox Drive, Johnson City, Tennessee (TN) 37604, United States (USA)
Fareva Morton Grove, Inc. FEI:(1410794) 6901 Golf Road, Morton Grove, Illinois (IL) 60053, United States (USA)
Horizon Pharmaceuticals, Inc. FEI:(3000718824) 971 W 15th St, Riviera Beach, Florida (FL) 33404, United States (USA)
I 3 PHARMACEUTICALS, LLC FEI:(3012763653) 200 Park Avenue, Warminster, Pennsylvania (PA) 18974, United States (USA)
IBSA Institut Biochimique SA FEI:(3002864272) Via Cantonale 16, Manno, TICINO 6928, Switzerland (CHE)
Innogenix, LLC. FEI:(3013326213) 8200 New Horizons Blvd, Amityville, New York (NY) 11701, United States (USA)
Kesin Pharma Corporation FEI:(3016965788) 101 Pine Avenue, Oldsmar, Florida (FL) 34677, United States (USA)
Kesin Pharma Corporation FEI:(3016965788) 3874 Tampa Rd Ste 103,, Oldsmar, Florida (FL) 34677-3126, United States (USA)
Larken Laboratories, Inc. FEI:(3005966786) 276 Nissan Parkway Building A, Suite 200, Canton, Mississippi (MS) 39046-7006, United States (USA)
Legacy Pharmaceutical Packaging, LLC FEI:(3004453700) 13333 Lakefront Drive, Earth City, Missouri (MO) 63045, United States (USA)
Lohxa FEI:(3014188920) 600 Main St Suite 110, Worcester, Massachusetts (MA) 01608, United States (USA)
Medefil, Inc. FEI:(3001677091) 250 Windy Point Drive, Glendale Heights, Illinois (IL) 60139, United States (USA)
Medefil, Inc. FEI:(3001677091) 405 Windy Point Drive, Glendale Heights, Illinois (IL) 60139, United States (USA)
MidAmerica Supplements FEI:(Dietary Supplements) 2237 South Outer Road Joplin, Missouri (MO) 64804 (USA)
Nephron SC Inc. FEI:(3010892830) 4500 12th Street Extension, West Columbia, South Carolina (SC) 29172, United States (USA)
Nephron Sterile Compounding Center, LLC FEI:(3011158388) 4500 12th Street Extension, West Columbia, South Carolina (SC) 29172, United States (USA)
Nexus Pharmaceuticals, LLC FEI:(3005191225) 400 Knightsbridge Parkway, Lincolnshire, Illinois (IL) 60069, United States (USA)
Nexus Pharmaceuticals, LLC FEI:(3017912110) 10300 128th Avenue, Pleasant Prarie, Wisconsin (WI) 53158-7336, United States (USA)
Oxford Pharmaceuticals, LLC FEI:(3012257735) 301 Leaf Lake Parkway, Birmingham, Alabama (AL) 35211, United States (USA)
Quality CDMO FEI:(3017569510) 5000 South Freeway Suite 106, Fort Worth, Texas (TX) 76115, United States (USA)
Sovereign Pharmaceuticals, LLC FEI:(3003229412) 7333 Jack Newel Blvd N, Fort Worth, Texas (TX) 76118, United States (USA)
Sovereign Pharmaceuticals, LLC FEI:(3003229412) 7549 Pebble Drive, Fort Worth, Texas (TX) 76118, United States (USA)
Sovereign Pharmaceuticals, LLC FEI:(3003229412) 7590 Sand Street, Fort Worth, Texas (TX) 76118, United States (USA)
LGP (CMO) Sunny Pharmtech Inc. FEI:(3013166187) No. 255, Longyuan 1st Rd., Longtan Dist., Hsinchu Science Park, Taoyuan City, 325002, Taiwan (TWN)
Teva Pharmaceuticals USA, Inc. FEI:(2245641) 8 Gloria Lane, Ste 10, Fairfield, New Jersey (NJ) 07004-3306, United States (USA)
Vita-Herb Nutriceuticals (VNHI) FEI:(Dietary Supplements) 172 E La Jolla Street Placentia, California (CA) 92870 (USA)
Xttrium Laboratories, Inc. FEI:(3008436464) 1200 E. Business Center Drive, Mount Prospect, Illinois (IL) 60056, United States (USA)
Xttrium Laboratories, Inc. FEI:(3017764383) 436 Park Avenue, Lake Villa, Illinois (IL) 60046, United States (USA)
United Pharma FEI:(12670763768) 2317 Moore Ave, Fullerton, CA 92833
GMP Nutrition Enterprises, Inc. FEI:(104702) 13653 Central Avenue, Chino, CA 91710
Tishcon Corp FEI:(11-2432386) 30 New York Ave, Westbury, NY 11590

Release Determination Statement (RDS-)

Manufacturer Information

Product Information

Production Batch/Lot Information

File Submissions