Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 81

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 81
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+III made at both our Los Angeles and Parets facilities to make Gamunex®;
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●   to use at our Los Angeles facility the Fraction II+III made at both our Los Angeles and Clayton facilities to make Gamunex®;
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●   to use Fraction V obtained at our Los Angeles facility to produce albumin at our Parets facility;
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●   to use Fraction V obtained at both our Clayton and Parets facilities to produce Albutein® in our Los Angeles facility;
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●   to use Fraction IV-1 obtained at our Los Angeles facility to produce Prolastina®, an A1PI we market in Spain, at our Clayton facility;
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●   to use Fraction IV-1 obtained at our Los Angeles facility to produce Prolastin®-C lyophilized at our Clayton facility;
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●   to use Fraction IV-1 obtained at our Clayton facility to produce Prolastin®-C liquid at our Parets facility;
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●   to use the same method currently in place in our Parets facility to produce Alphanate® in our Los Angeles facility;
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●   to use paste from the fractionation facility at Clayton to produce Gamunex® and Prolastin®;
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●   to produce nano-filtered Gamunex® and the 40 gram vial presentation; and
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●   to use Cryoprecipitate obtained at our Clayton facility to produce Alphanate® at our Clayton facility, which is later sent to our Los Angeles facility to be filled.
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We are continuing our efforts to obtain additional FDA licenses of this nature. The flexibility provided through such licenses allows us to increase production efficiency and to better address changes in demand between the United States, the European Union and other world markets.
For more information on our manufacturing facilities, see “—D. Property, Plant and Equipment” below.
Safety
We have never experienced a mandatory recall of any batch of our finished biological products due to a safety risk. In alignment with our commitment to safety and quality, we have in the past voluntarily withdrawn some product lots not comprised of finished biological products as a precautionary measure due to a higher rate of allergic/hypersensitivity type reactions that we found to be isolated to a small subset of plasma donors. These withdrawals were conducted with the knowledge of the governmental authorities of the applicable jurisdictions. Our philosophy is that the health of the plasma donor and