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Last Updated: November 29, 2021

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Suppliers and packages for biologic ingredient: alpha-1-proteinase inhibitor (human)

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Suppliers and packages for biologic ingredient: alpha-1-proteinase inhibitor (human)

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities
Applicant Tradename Biologic Ingredient Dosage BLA NDA/ANDA Supplier Package Code Package
Grifols Therapeutics Llc PROLASTIN, PROLASTIN-C alpha-1-proteinase inhibitor (human) For Injection 103174 BLA GRIFOLS USA, LLC 13533-700-02 1 KIT in 1 CARTON (13533-700-02) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-702-11) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-000-06)
Grifols Therapeutics Llc PROLASTIN, PROLASTIN-C alpha-1-proteinase inhibitor (human) For Injection 103174 BLA GRIFOLS USA, LLC 13533-703-10 1 KIT in 1 CARTON (13533-703-10) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-702-11) * 20 mL in 1 VIAL, SINGLE-DOSE (13533-200-20)
Grifols Therapeutics Llc PROLASTIN, PROLASTIN-C alpha-1-proteinase inhibitor (human) For Injection 103174 BLA GRIFOLS USA, LLC 13533-705-01 1 VIAL in 1 CARTON (13533-705-01) > 20 mL in 1 VIAL (13533-705-11)
Grifols Therapeutics Llc PROLASTIN, PROLASTIN-C alpha-1-proteinase inhibitor (human) For Injection 103174 BLA GRIFOLS USA, LLC 13533-705-31 1 VIAL in 1 CARTON (13533-705-31) > 10 mL in 1 VIAL (13533-705-32)
Grifols Therapeutics Llc PROLASTIN, PROLASTIN-C alpha-1-proteinase inhibitor (human) For Injection 103174 BLA GRIFOLS USA, LLC 13533-705-51 1 VIAL in 1 CARTON (13533-705-51) > 80 mL in 1 VIAL (13533-705-52)
Baxalta Us Inc. ARALAST, ARALAST NP alpha-1-proteinase inhibitor (human) For Injection 125039 BLA Baxalta U.S. Inc. 0944-2814-01 1 KIT in 1 CARTON (0944-2814-01) * 25 mL in 1 VIAL (0944-2803-03) * 25 mL in 1 VIAL, GLASS
>Applicant >Tradename >Biologic Ingredient >Dosage >BLA >NDA/ANDA >Supplier >Package Code >Package

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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Moodys
Merck
McKinsey
Johnson and Johnson