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Generated: August 24, 2019

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Patent: 10,011,643

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Summary for Patent: 10,011,643
Title:Freeze-dried preparation containing high-purity PTH and method for producing same
Abstract: [Problem] Provided is a freeze-dried preparation containing high-purity PTH peptide and a method for the production thereof. Also provided is a test method for PTH analogs to confirm the purity of a freeze-dried preparation containing PTH peptide, and the like. [Solution] In the present invention, the presence of PTH analogs produced during the manufacturing process of a freeze-dried preparation containing PTH peptide was confirmed. The production of these PTH analogs was also discovered to be markedly prevented or reduced by controlling exposure of the solution containing PTH peptide and the like to air environments within a pharmaceutical production facility.
Inventor(s): Nishio; Fumihide (Tokyo, JP), Maejima; Takuji (Tokyo, JP), Mitome; Yoshiro (Tokyo, JP)
Assignee: ASAHI KASEI PHARMA CORPORATION (Tokyo, JP)
Application Number:14/990,948
Patent Claims:see list of patent claims

Details for Patent 10,011,643

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 004 2015-01-23 ➤ Sign Up ASAHI KASEI PHARMA CORPORATION (Tokyo, JP) 2031-06-07 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 003 2015-01-23 ➤ Sign Up ASAHI KASEI PHARMA CORPORATION (Tokyo, JP) 2031-06-07 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 002 2015-01-23 ➤ Sign Up ASAHI KASEI PHARMA CORPORATION (Tokyo, JP) 2031-06-07 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 001 2015-01-23 ➤ Sign Up ASAHI KASEI PHARMA CORPORATION (Tokyo, JP) 2031-06-07 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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