Available EU DMF/CEP
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CEP
API Status
Commercial
Pipeline
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
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Available US DMF
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Available Japanese/Chinese DMF
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Risedronate sodium

CAS No.

115436-72-1

Innovator/marketer

Actonel, Benet

Polymorphic form

Form A

Therapeutic Area

Musculo-skeletal system

Status

Commercial

EU DMF readiness

US DMF readiness

020384

CEP

Other documentation

Japanese DMF
Korean DMF

Drug description:

Risedronate sodium is a pyridines derivative drug which belongs to the class of bone density conservation agents.
Risedronate sodium is indicated for treatment and prevention of osteoporosis in postmenopausal women, glucocorticoid-induced osteoporosis in men and women and treatment of osteoporosis in men, and also used for treatment of Paget's disease of bone.
It is formulated as tablets, film-coated tablet for oral route of administration.

Mechanism of action:

Risedronate sodium is a pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. The bone turnover is reduced while the osteoblast activity and bone mineralization is preserved.

DISCLAIMER
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).

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