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• Guidelines for Selecting Active Pharmaceutical Ingredient Suppliers for a US-based Pharmaceutical Manufacturer
• cGMPs for Active Pharmaceutical Ingredient (API) and Excipient Production

• FDA: Office of Generic Drugs
• European Generic medicines Association (EGA)

Guidance for Industry Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs (Dec. 2000)

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Office of Generic Drugs

This guidance is intended to describe the Office of Generic Drugs' (OGD) policy on the use of alternate sources of the active pharmaceutical ingredients (API) in unapproved abbreviated new drug applications (ANDAs). The guidance describes the circumstances under which an alternate source can be used. This guidance is intended to decrease the regulatory burden on industry and provide a more consistent approach to pre- and postapproval changes in API sources.

This guidance replaces the OGD memorandum dated July 26, 1996, titled, Substitution of an Alternate Source of the New Drug Substance in Unapproved Abbreviated Applications.

Generics - FDA Guidance Document

• 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day [Word] or [PDF] (Issued 7/2003, Posted 7/31/2003)

• Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs [HTML] or [PDF] (Posted 12/12/2000)
• ANDA's: Impurities in Drug Substances [HTML] or [PDF]  (Issued 11/1999, Posted 12/2/1999)
• Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act [HTML] or [PDF]  (Posted 3/27/2000)
• Handling and Retention of BA and BE Testing Samples [Word] or [PDF] (5/25/2004)
• Letter announcing that the OGD will now accept the ICH long-term storage conditions as well as the stability studies conducted in the past. (Posted 3/2/1998)
• Letter describing efforts by the CDER and the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new and abbreviated drug approval process in order to reduce duplication or redundancy in the process (Posted 3/2/1998)
• Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy (Posted 3/2/1998)
• Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters (Posted 3/2/1998)
• Letter on the provision of new procedures and policies affecting the generic drug review process (Posted 3/2/1998)
• Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions (Posted 3/2/1998)
• Letter on the response to 12/20/1984 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act (Posted 3/2/1998)
• Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse-to-file incomplete submissions as required by the new law (Posted 3/2/1998)
• Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements (Posted 3/2/1998)
• Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications [PDF] (Issued 12/2001, Posted 12/20/2001)
• Organization of an ANDA (Issued 2/1999, 3/2/1999)
• Revising ANDA Labeling Following Revision of the RLD Labeling [HTML] or [PDF] (Issued 4/26/2000, 4/26/2000)
• Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products [HTML] or [PDF]  (Issued 12/1999, Posted 2/3/2000)
• Variations in Drug Products that May Be Included in a Single ANDA (Issued 12/1998, Posted 1/26/1999)

Generics (Draft) - FDA Guidance Document

• ANDAs: Impurities in Drug Products (Issued 12/1998, Posted 1/5/1999)
• Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 -- Questions and Answers [HTML] or [Word] or [PDF]. (Issued 10/2004, Posted 11/3/2004)

Over-the-Counter (OTC) Guidances - FDA Guidance Document

• Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16) (Posted 3/2/1998)
• General Guidelines for OTC Combination Products (Posted 3/2/1998)
• Labeling OTC Human Drug Products Using a Column Format [HTML] or [PDF] (Issued 12/2000, Posted 12/18/2000)
• Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs [Word] or [PDF] 
  Example Drug Facts Labels
  • Acetaminophen 120 mg in a Suppository Dosage Form [PDF]
  • Acetaminophen 325 mg in a Suppository Dosage Form [PDF]
  • Acetaminophen 650 mg in a Suppository Dosage Form [PDF]
  • Cimetidine 200 mg in a Tablet Dosage Form [PDF]
  • Clemastine Fumerate 1.34 mg in a Tablet Dosage Form [PDF]
  • Doxylamine Succinate 25 mg Tablet Dosage Form [PDF]
  • Ibuprofen 200 mg in a Tablet/Capsule Dosage Form [PDF]
  • Loperamide HCl in a Liquid Dosage Form [PDF]
  • Loperamide HCl in a Tablet/Caplet Dosage Form [PDF]
  • Miconazole Nitrate Vaginal Products [PDF]
  • Minoxidil Topical Solution 2% for Men and Women [PDF]
  • Minoxidil Topical Solution 5% for Men [PDF]
  • Naproxen Sodium 220 mg in a Tablet/Caplet/Gelcap Dosage Form [PDF]
  • Pseudoephedrine HCl Extended-Release Tablets 120 mg [PDF]
• Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731) (Posted 3/2/1998)

Over-the-Counter (OTC) Draft - FDA Guidance Document

• Labeling OTC Human Drug Products -Submitting Requests for Exemptions and Deferrals [HTML] or [PDF] (Issued 12/2000, Posted 12/18/2000)
• Labeling OTC Human Drug Products Updating Labeling in ANDAs [HTML] or [PDF] (2/21/2001)
  • Additional examples 1 (3/19/2001)
  • Additional examples 2 (3/26/2001)
  • Additional examples 3 (3/26/2001)
• Time and Extent Applications [PDF] or [Word] (Issued 2/2004, Posted 2/11/2004)
• Labeling OTC Human Drug Products (Small Entity Compliance Guide) [HTML] or [WORD] or [PDF] (Issued 12/2004; Posted 12/08/2004)

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