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When can the change be implemented

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Company A is in the process of performing a manufacturing site transfer for Betaxolol Tablets USP, 10 mg and 20 mg to Company B. Company B has performed capsule operations only in the past and maintains a satisfactory GMP Inspection status for capsules operations only.

1. What type of submission is required for this change?

2. When can the change be implemented?

Reference no: EM133308394

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