ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information: Guidance for Industry | Guideline Explorer

Description

Chemistry, manufacturing, and controls (CMC) information must be submitted to support the approval of an abbreviated new drug application (ANDA). This guidance is intended to assist applicants with the submission of ANDAs when a drug substance exists in polymorphic forms.

Scope & Applicability

Product Classes

4

Generic drug product

product for which approval is sought in an ANDA

Reference listed drug

The drug referenced by an ANDA.

Solid oral dosage form

General category for tablets and capsules discussed in the coating and drilling sections.

Suspension dosage form

Investigating whether to set specifications for polymorphs for solid oral and suspension dosage form products.

Regulatory Context

Attributes

4

Solubility

Property used in the decision tree for in-vitro testing

Stability

A functional role of sodium in food

Melting point

Is there a polymorph specification in the USP (e.g., melting point)?

Thermodynamically stable polymorphic form

In general, there may not be a concern if the most thermodynamically stable polymorphic form is used.

Related CFR Sections (3)

21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
21CFR320.1§ 320.1 Definitions.
The definitions contained in § 314.3 of this chapter apply to those terms when used in this part.Read full regulation →
21CFR314.92§ 314.92 Drug products for which abbreviated applications may be submitted.
(a) Abbreviated applications are suitable for the following drug products within the limits set forth under § 314.93 :Read full regulation →