Monday, October 31, 2022 12:13:17 PM
I believe there is some wiggle room. There are actually two different quotas, an API procurement quota and a product manufacturing quota. The mismatch between the two numbers gives them some leeway. For instance, if they have used all of the procurement quota for IR but not yet reached their IR manufacturing quota, then they could potentially take some of their XR procurement quota and use it to make IR product, or vice versa. As long as all of the API is accounted for and neither drug's manufacturing quota is exceeded, then they have some (but probably not a lot of) discretion about which product gets more of the API. Basically, they can decide to max out the manufacturing quota of one product at the expense of the other product.
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