Is Cinacalcet registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 15 valid registrations of Cinacalcet, including CINAC 30 MG FILM COATED TABLET (30 mg, Film-coated tablet, SAR 268.05); CINAC 60 MG FILM COATED TABLET (60 mg, Film-coated tablet, SAR 498.00); Cincet (60 mg, Film-coated tablet, SAR 451.85); Cincet (30 mg, Film-coated tablet, SAR 221.20); ENDOLET 30 mg film-coated tablet (30 mg, Film-coated tablet, SAR 672.20).

Is Cinacalcet approved by the US FDA?

Drugs@FDA lists 15 application product lines for Cinacalcet, including CINACALCET HYDROCHLORIDE (Prescription); CINACALCET HYDROCHLORIDE (Prescription); CINACALCET HYDROCHLORIDE (Prescription); CINACALCET HYDROCHLORIDE (Prescription); CINACALCET HYDROCHLORIDE (Prescription).

Is Cinacalcet authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Cinacalcet: Cinacalcet Viatris (previously Cinacalcet Mylan), Cinacalcet Accordpharma.

Are there safety signals or safety updates for Cinacalcet?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2019-12-05).

Active substance

Cinacalcet

SFDA 20
US FDA 15
EMA 4
Health Canada 22
US price lines 3
NHS prices 3
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CINAC 30 MG FILM COATED TABLET	30 mg	Film-coated tablet · Oral use	28 Blister	SAR 268.05	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
CINAC 60 MG FILM COATED TABLET	60 mg	Film-coated tablet · Oral use	28 Blister	SAR 498.00	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Cincet	60 mg	Film-coated tablet · Oral use	28 Blister	SAR 451.85	Generic · Prescription	Aurobindo Pharma Saudi Arabia Limited	Valid
Cincet	30 mg	Film-coated tablet · Oral use	28 Blister	SAR 221.20	Generic · Prescription	Aurobindo Pharma Saudi Arabia Limited	Valid
ENDOLET 30 mg film-coated tablet	30 mg	Film-coated tablet · Oral use	28 Blister	SAR 672.20	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
ENDOLET 60 mg film-coated tablet	60 mg	Film-coated tablet · Oral use	28 Blister	SAR 1300.85	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
ENDOLET 90 mg film-coated tablet	90 mg	Film-coated tablet · Oral use	28 Blister	SAR 1589.50	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
GLANDY 30 mg film-coated tablet	30 mg	Film-coated tablet · Oral use	28 Blister	SAR 636.85	Generic · Prescription	SPIMACO ADDWAEIH	Valid
GLANDY 60 mg film-coated tablet	60 mg	Film-coated tablet · Oral use	28 Blister	SAR 1232.35	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Glandacet	90 mg	Film-coated tablet · Oral use	28 Blister	SAR 734.00	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Glandacet	60 mg	Film-coated tablet · Oral use	28 Blister	SAR 498.00	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Glandacet	30 mg	Film-coated tablet · Oral use	28 Blister	SAR 268.00	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Lanacet	90 mg	Film-coated tablet · Oral use	28 Blister	SAR 1510.05	Generic · Prescription	ADEL AHMED AL-SHAEIR PHARMACEUTICAL COMPANY	Valid
Lanacet	60 mg	Film-coated tablet · Oral use	30 Blister	SAR 1019.20	Generic · Prescription	ADEL AHMED AL-SHAEIR PHARMACEUTICAL COMPANY	Valid
Lanacet	30 mg	Film-coated tablet · Oral use	30 Blister	SAR 526.65	Generic · Prescription	ADEL AHMED AL-SHAEIR PHARMACEUTICAL COMPANY	Valid
CINAC 90 MG FILM COATED TABLET	90 mg	Film-coated tablet · Oral use	28 Blister	SAR 734.40	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Withdrawn by MAH · Not Marketed
GLANDY 90 mg film-coated tablet	90 mg	Film-coated tablet · Oral use	28 Blister	SAR 1430.55	Generic · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed
MIMPARA 30MG F.C. TABLETS	30 mg	Film-coated tablet · Oral use	28 Blister	SAR 707.60	NCE · Prescription	AMGEN EUROPE B.V.	Withdrawn by MAH · Not Marketed
MIMPARA 60MG F.C. TABLETS	60 mg	Film-coated tablet · Oral use	28 Blister	SAR 1369.30	NCE · Prescription	AMGEN EUROPE B.V.	Withdrawn by MAH · Not Marketed
MIMPARA 90MG F.C. TABLETS	90 mg	Film-coated tablet · Oral use	28 Blister	SAR 1956.30	NCE · Prescription	AMGEN EUROPE B.V.	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE-MINERAL AND BONE DISORDERS; HYPERPARATHYRODISM; PARATHYROID CANCER - HYPERCALCEMIA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	AUROBINDO PHARMA LTD	Prescription	8 Mar 2018
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	CIPLA	Prescription	8 Mar 2018
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	STRIDES PHARMA	Prescription	30 Apr 2018
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	PIRAMAL	Prescription	1 Aug 2018
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	WATSON LABS TEVA	Prescription	27 Dec 2018
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	ALKEM LABS LTD	Prescription	17 May 2019
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	ACCORD HLTHCARE	Prescription	15 May 2020
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	CHARTWELL RX	Prescription	18 May 2020
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	DR REDDYS	Prescription	18 Sep 2020
SENSIPAR	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	AMGEN	Discontinued	8 Mar 2004
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	SUN PHARM	Discontinued	11 Oct 2018
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	RISING	Discontinued	16 Oct 2018
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	LUPIN	Discontinued	28 Jun 2019
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	HETERO LABS LTD V	Discontinued	7 Oct 2020
CINACALCET HYDROCHLORIDE	EQ 30MG BASE; EQ 60MG BASE; EQ 90MG BASE	tablet · oral	STEVENS J	Discontinued	2 Dec 2021

EMA European Union — centrally authorised medicines

Cinacalcet Viatris (previously Cinacalcet Mylan) Mylan Pharmaceuticals Limited · Authorised · authorised 19 Nov 2015 · ATC H05BX01

Therapeutic indication (EMA)

Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate. Reduction of hypercalcaemia in patients with: parathyroid carcinoma primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Cinacalcet Accordpharma Accord Healthcare S.L.U. · Authorised · authorised 3 Apr 2020 · ATC H05BX01

Therapeutic indication (EMA)

Secondary hyperparathyroidism AdultsTreatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric populationTreatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4). Cinacalcet Accordpharma may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1). Parathyroid carcinoma and primary hyperparathyroidism in adults Reduction of hypercalcaemia in adult patients with: parathyroid carcinoma. primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Mimpara Amgen Europe B.V. · Withdrawn · authorised 22 Oct 2004 · ATC H05BX01

Therapeutic indication (EMA)

Secondary hyperparathyroidism Adults Treatment of secondary hyperparathyroidism (HPT) in adult patients with end stage renal disease (ESRD) on maintenance dialysis therapy. Paediatric population Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy. Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate. Parathyroid carcinoma and primary hyperparathyroidism in adults. Reduction of hypercalcaemia in adult patients with: parathyroid carcinoma; primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Parareg Dompé Biotec S.p.A. · Withdrawn · authorised 22 Oct 2004 · ATC H05BX01

Therapeutic indication (EMA)

Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1). Reduction of hypercalcaemia in patients with: parathyroid carcinoma. primary HPT for whom parathyroidectomy would be indicated on the basis of serum calciumlevels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-CINACALCET	02452693	30 MG	TABLET · ORAL	APOTEX INC
APO-CINACALCET	02452707	60 MG	TABLET · ORAL	APOTEX INC
APO-CINACALCET	02452715	90 MG	TABLET · ORAL	APOTEX INC
AURO-CINACALCET	02478900	30 MG	TABLET · ORAL	AURO PHARMA INC
AURO-CINACALCET	02478919	60 MG	TABLET · ORAL	AURO PHARMA INC
AURO-CINACALCET	02478943	90 MG	TABLET · ORAL	AURO PHARMA INC
CINACALCET	02524880	30 MG	TABLET · ORAL	SANIS HEALTH INC
JAMP CINACALCET TABLETS	02500094	30 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP CINACALCET TABLETS	02500108	60 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP CINACALCET TABLETS	02500116	90 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
M-CINACALCET	02481987	30 MG	TABLET · ORAL	MANTRA PHARMA INC
M-CINACALCET	02481995	60 MG	TABLET · ORAL	MANTRA PHARMA INC
M-CINACALCET	02482002	90 MG	TABLET · ORAL	MANTRA PHARMA INC
MAR-CINACALCET	02480298	30 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MAR-CINACALCET	02480301	60 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MAR-CINACALCET	02480328	90 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MYLAN-CINACALCET	02434539	30 MG	TABLET · ORAL	MYLAN PHARMACEUTICALS ULC
MYLAN-CINACALCET	02434547	60 MG	TABLET · ORAL	MYLAN PHARMACEUTICALS ULC
MYLAN-CINACALCET	02434555	90 MG	TABLET · ORAL	MYLAN PHARMACEUTICALS ULC
TEVA-CINACALCET	02441624	30 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-CINACALCET	02441632	60 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-CINACALCET	02441640	90 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CINACALCET HCL 30 MG TABLET	$0.41139	per EA	23 Sep 2026
US NADAC	CINACALCET HCL 60 MG TABLET	$0.76582	per EA	23 Sep 2026
US NADAC	CINACALCET HCL 90 MG TABLET	$1.06212	per EA	23 Sep 2026
NHS Drug Tariff	Cinacalcet 30mg tablets	£4.01	28 tablet	1 Oct 2026
NHS Drug Tariff	Cinacalcet 60mg tablets	£10.44	28 tablet	1 Oct 2026
NHS Drug Tariff	Cinacalcet 90mg tablets	£295.77	28 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 5 Dec 2019 SENSIPAR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 7 Mar 2013 PRAC signal: Fatal case with severe hypocalcemia in a pediatric clinical study
Action for MAH: update of the product information: Yes
EMA PRAC 29 Nov 2012 PRAC signal: QT prolongation/ventricular arrhythmias
Action for MAH: update of the product information: No
EMA PRAC 5 Sep 2012 PRAC signal: QT prolongation/ventricular arrhythmias
Action for MAH: update of the product information: Yes

All safety entries for cinacalcet →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.