A. DRUG ESTABLISHMENT REGISTRATION NUMBER

B. ADDRESS

I. ADMINISTRATIVE

II. MANUFACTURING FACILITIES

III. RESPONSIBLE U.S. AGENT

C. STATEMENT OF COMMITMENT

D. ORGANIZATION AND PERSONNEL

E. BUILDINGS AND FACILITIES

F. EQUIPMENT

G. ARTICLE - COMPONENTS AND COMPOSITION

I. DESCRIPTION OF THE ACTIVE PHARMACEUTICAL INGREDIENT

II. MANUFACTURE OF THE ACTIVE PHARMACEUTICAL INGREDIENT

III. MANUFACTURE OF THE REFERENCE STANDARD

IV. PACKAGING AND LABELING

H. PRODUCTION AND PROCESS CONTROLS

I. MASTER AND BATCH PRODUCTION RECORDS

II. IN-PROCESS SAMPLING PROCEDURE

III. FINAL PRODUCT SAMPLING PROCEDURE

IV. REPROCESSING PROCEDURES

V. PACKAGING AND LABELING

I. LABORATORY CONTROLS

I. SPECIFICATIONS, TEST METHODS, AND SAMPLING PLAN USED FOR RAW MATERIALS

II. SPECIFICATIONS, TEST METHODS, AND SAMPLING PLAN USED

III. SPECIFICATIONS, TEST METHODS, AND SAMPLING PLAN USED FOR INTERMEDIATES

IV. IN-PROCESS CONTROLS

V. SPECIFICATIONS, TEST METHODS, AND SAMPLING PLAN USED FOR THE ACTIVE PHARMACEUTICAL INGREDIENT

VI. STABILITY PROTOCOL

VII. PRODUCT PROBLEM REPORT AND RESPONSE

J. ENVIRONMENTAL IMPACT ANALYSIS

I. ENVIRONMENTAL LABORATORY - MONITORING

II. ENVIRONMENTAL ASSESSMENT - 21 CFR 25.31a(a)6

K. MISCELLANEOUS