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Chemistry

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Also known as: Berotralstat, 1809010-50-1, Bcx7353, Berotralstat [inn], Berotralstat [usan], Xza0kb1bdq
Molecular Formula
C30H26F4N6O
Molecular Weight
562.6  g/mol
InChI Key
UXNXMBYCBRBRFD-MUUNZHRXSA-N
FDA UNII
XZA0KB1BDQ

Berotralstat Hydrochloride
Berotralstat is a selective inhibitor of plasma kallikrein used in the prophylaxis of attacks of hereditary angioedema (HAE). It works by blocking the enzymatic activity of plasma kallikrein in releasing bradykinin, the major biologic peptide that promotes swelling and pain associated with attacks of HAE. Developed by BioCryst Pharmaceuticals, berotralstat is taken once-daily as oral capsules. Under the market name Orladeyo, berotralstat was approved by the FDA on December 3, 2020, as the first oral, once-daily therapy to prevent angioedema attacks of HAE in adults and pediatric patients 12 years and older. In clinical trials, berotralstat was shown to significantly reduce attack rates at 24 weeks compared to placebo, which was sustained through 48 weeks. Berotralstat is strictly used to prevent, but not treat, these attacks. Previous oral therapies used for prophylaxis of HAE attacks, such as androgens, were limited by undesirable adverse effects and several contraindications. In clinical trials, berotralstat displayed a fast onset of action, long duration of action, and acceptable tolerance in patients.
Berotralstat is a Plasma Kallikrein Inhibitor. The mechanism of action of berotralstat is as a Kallikrein Inhibitor, and Cytochrome P450 2D6 Inhibitor, and Cytochrome P450 3A4 Inhibitor, and P-Glycoprotein Inhibitor.
1 2D Structure

Berotralstat Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[3-(aminomethyl)phenyl]-N-[5-[(R)-(3-cyanophenyl)-(cyclopropylmethylamino)methyl]-2-fluorophenyl]-5-(trifluoromethyl)pyrazole-3-carboxamide
2.1.2 InChI
InChI=1S/C30H26F4N6O/c31-24-10-9-22(28(37-17-18-7-8-18)21-5-1-3-19(11-21)15-35)13-25(24)38-29(41)26-14-27(30(32,33)34)39-40(26)23-6-2-4-20(12-23)16-36/h1-6,9-14,18,28,37H,7-8,16-17,36H2,(H,38,41)/t28-/m1/s1
2.1.3 InChI Key
UXNXMBYCBRBRFD-MUUNZHRXSA-N
2.1.4 Canonical SMILES
C1CC1CNC(C2=CC(=C(C=C2)F)NC(=O)C3=CC(=NN3C4=CC=CC(=C4)CN)C(F)(F)F)C5=CC=CC(=C5)C#N
2.1.5 Isomeric SMILES
C1CC1CN[C@@H](C2=CC(=C(C=C2)F)NC(=O)C3=CC(=NN3C4=CC=CC(=C4)CN)C(F)(F)F)C5=CC=CC(=C5)C#N
2.2 Other Identifiers
2.2.1 UNII
XZA0KB1BDQ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide

2. 1h-pyrazole-5-carboxamide, 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)

3. Bcx-7353

4. Bcx7353

5. Berotralstat

2.3.2 Depositor-Supplied Synonyms

1. Berotralstat

2. 1809010-50-1

3. Bcx7353

4. Berotralstat [inn]

5. Berotralstat [usan]

6. Xza0kb1bdq

7. Bcx-7353

8. Berotralstat (usan)

9. 2-[3-(aminomethyl)phenyl]-n-[5-[(r)-(3-cyanophenyl)-(cyclopropylmethylamino)methyl]-2-fluorophenyl]-5-(trifluoromethyl)pyrazole-3-carboxamide

10. 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide

11. 1h-pyrazole-5-carboxamide, 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-

12. 1-[3-(aminomethyl)phenyl]-n-(5-{(r)-(3-cyanophenyl)[(cyclopropylmethyl)amino]methyl}-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide

13. Unii-xza0kb1bdq

14. Berotralstat [usan:inn]

15. Berotralstat [who-dd]

16. Schembl21974728

17. Gtpl11347

18. Dtxsid401336676

19. Ex-a5537

20. Who 10907

21. Hy-109127

22. Cs-0086757

23. D11673

24. (r)-1-(3-(aminomethyl)phenyl)-n-(5-((3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide

25. 0ri

26. 1-[3-(aminomethyl)phenyl]-n-(5-{(r)-[3-(aminomethyl)phenyl][(cyclopropylmethyl)amino]methyl}-2-fluorophenyl)-3-(trifluoromethyl)-1h-pyrazole-5-carboxamide

27. 1h-pyrazole-5-carboxamide, 1-(3-(aminomethyl)phenyl)-n-(5-((r)-(3-cyanophenyl)((cyclopropylmethyl)

2.4 Create Date
2019-03-16
3 Chemical and Physical Properties
Molecular Weight 562.6 g/mol
Molecular Formula C30H26F4N6O
XLogP34.5
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count9
Rotatable Bond Count9
Exact Mass562.21042212 g/mol
Monoisotopic Mass562.21042212 g/mol
Topological Polar Surface Area109 Ų
Heavy Atom Count41
Formal Charge0
Complexity938
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Berotralstat is indicated for prophylaxis of attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. It is not used for the treatment of acute HAE attacks.


Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Berotralstat prevents angioedema attacks by inhibiting plasma kallikrein, thereby regulating excess bradykinin generation in patients with hereditary angioedema. It has a fast onset of action, long duration of action, and acceptable tolerance. Berotralstat inhibits plasma kallikrein in a concentration-dependent. In clinical trials, doses of berotralstat higher than 150 mg once daily led to QT Prolongation in a concentration-dependent manner.


5.2 MeSH Pharmacological Classification

Serine Proteinase Inhibitors

Exogenous or endogenous compounds which inhibit SERINE ENDOPEPTIDASES. (See all compounds classified as Serine Proteinase Inhibitors.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
BEROTRALSTAT
5.3.2 FDA UNII
XZA0KB1BDQ
5.3.3 Pharmacological Classes
Mechanisms of Action [MoA] - P-Glycoprotein Inhibitors
5.4 ATC Code

B06AC


B - Blood and blood forming organs

B06 - Other hematological agents

B06A - Other hematological agents

B06AC - Drugs used in hereditary angioedema

B06AC06 - Berotralstat


5.5 Absorption, Distribution and Excretion

Absorption

The steady-state of berotralstat is reached within 6 to 12 days following initial administration. After once-daily administration, the Cmax and AUC of berotralstat at steady-state is approximately five times that of the drug after a single dose. Following oral administration of berotralstat once-daily, the steady-state Cmax was 158 ng/mL (range: 110 to 234 ng/mL) at the dose of 150 mg and 97.8 ng/mL (range: 63 to 235 ng/mL) at the dose of 110 mg. The area under the curve over the dosing interval (AUCtau) was 2770 ng*hr/mL (range: 1880 to 3790 ng*hr/mL) and 1600 ng*hr/mL (range: 950 to 4170 ng*hr/mL) at the dose of 110 mg. The median Tmax is 2 hours in a fasted state and a high-fat meal delays the Tmax to 5 hours. The Tmax can range from 1 to 8 hours.


Route of Elimination

Following a single oral dose administration of 300 mg radiolabeled berotralstat, approximately 9% of the drug was excreted in the urine, where 1.8 to 4.7% of the total radiolabeled compound accounted for the unchanged parent drug. About 79% of the drug was excreted in feces.


Volume of Distribution

The blood to plasma ratio was approximately 0.92 following a single 300 mg dose administration of radiolabeled berotralstat.


Clearance

There is no information on the clearance rate.


5.6 Metabolism/Metabolites

Berotralstat is metabolized by CYP2D6 and CYP3A4. The metabolic pathway and the metabolites of berotralstat have not yet been characterized. Following a single oral dose administration of 300 mg radiolabeled berotralstat, about 34% of the total plasma radioactivity accounted for the unchanged drug while about eight detectable metabolites accounted for 1.8 to 7.8% of the total radioactivity.


5.7 Biological Half-Life

Following a single oral dose administration of 300 mg radiolabeled berotralstat, the median elimination half-life of berotralstat was approximately 93 hours, ranging from 39 to 152 hours.


5.8 Mechanism of Action

Hereditary angioedema (HAE) is a rare genetic disorder associated with severe swelling of the skin and upper airway. It is caused by mutations in the regulatory or coding regions of the gene that encodes C1 inhibitor (SERPING1), which result in either a deficiency (type I) or dysfunction (type II) of C1 inhibitor (C1 esterase inhibitor, C1-INH). C1 inhibitor is a serine protease inhibitor that normally regulates bradykinin production by covalently binding to and inactivating plasma kallikrein. Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK). During HAE attacks, the levels of plasma kallikrein fall, leading to the cleavage of high-molecular-weight-kininogen and the release of bradykinin, a potent vasodilator that increases vascular permeability. Bradykinin plays a major role in promoting edema and pain associated with HAE. Patients with HAE cannot properly regulate plasma kallikrein activity due to the deficiency or dysfunction of a serum inhibitor of C1 inhibitor, leading to uncontrolled increases in plasma kallikrein activity and recurrent angioedema attacks. Berotralstat is a potent inhibitor of plasma kallikrein that works by binding to plasma kallikrein and blocking its proteolytic activity, thereby controlling excess bradykinin generation.


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Apicore

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Hetero Drugs

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BEROTRALSTAT HYDROCHLORIDE

NDC Package Code : 59116-5570

Start Marketing Date : 2018-06-28

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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BEROTRALSTAT DIHYDROCHLORIDE

NDC Package Code : 12651-120

Start Marketing Date : 2021-01-13

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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BEROTRALSTAT DIHYDROCHLORIDE

NDC Package Code : 68554-0167

Start Marketing Date : 2020-12-03

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Apicore

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Berotralstat Hydrochloride

About the Company : Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide p...

Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide portfolio of services ranging from API’s for the generic industry to custom synthesis for early phase pharmaceutical research and branded products. Our USFDA approved facilities in India (Visakhapatnam, Andhra Pradesh and Vadodara, Gujarat) are both equipped with state-of-the-art analytical and research capabilities. While our worldwide network of locations seamlessly integrate with each other, each unit also independently houses a full
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Berotralstat Hydrochloride

About the Company : Hetero, we are one of world’s leading producers of key Active Pharmaceutical Ingredients (APIs) and generic formulations with presence in 140+ countries and backed by 30 years of...

Hetero, we are one of world’s leading producers of key Active Pharmaceutical Ingredients (APIs) and generic formulations with presence in 140+ countries and backed by 30 years of experience in the pharma sector. We endeavour to serve patients by moulding science and technology into therapies to improve health outcomes and people’s lives.
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Details:

Under the agreement, BioCryst sell will its European Orladeyo (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, business to Neopharmed Gentili.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Neopharmed Gentili

Deal Size: $264.0 million Upfront Cash: $250.0 million

Deal Type: Divestment June 27, 2025

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Details : Under the agreement, BioCryst sell will its European Orladeyo (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, business to Neopharmed Gentili.

Product Name : Orladeyo

Product Type : Other Small Molecule

Upfront Cash : $250.0 million

June 27, 2025

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Details:

Orladeyo (berotralstat), plasma kallikrein inhbitor, which is being evaluated for the treatment in pediatric patients with hereditary angioedema aged 2 to <11 years.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 14, 2025

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Pharmex
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Details : Orladeyo (berotralstat), plasma kallikrein inhbitor, which is being evaluated for the treatment in pediatric patients with hereditary angioedema aged 2 to <11 years.

Product Name : Orladeyo

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 14, 2025

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Details:

Orladeyo (berotralstat) is a first oral, once-daily therapy which is approved for the treatment of patients with hereditary angioedema.


Lead Product(s): Berotralstat Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Orladeyo

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 03, 2020

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Details : Orladeyo (berotralstat) is a first oral, once-daily therapy which is approved for the treatment of patients with hereditary angioedema.

Product Name : Orladeyo

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 03, 2020

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BIOCRYST

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BEROTRALSTAT HYDROCHLORIDE

Brand Name : ORLADEYO

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 110MG BASE

Approval Date : 2020-12-03

Application Number : 214094

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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BEROTRALSTAT HYDROCHLORIDE

Brand Name : ORLADEYO

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2020-12-03

Application Number : 214094

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Berotralstatum

Brand Name : Orladeyo

Dosage Form : Kaps

Dosage Strength : 150mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Berotralstat Hydrochloride

Dosage Form : Kaps

Dosage Strength : 150mg

Price Per Pack (Euro) : 12756.64

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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US Patents

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BIOCRYST

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BEROTRALSTAT HYDROCHLORIDE

US Patent Number : 11618733

Drug Substance Claim :

Drug Product Claim :

Application Number : 214094

Patent Use Code : U-3300

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-11-01

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BEROTRALSTAT HYDROCHLORIDE

US Patent Number : 11708333

Drug Substance Claim :

Drug Product Claim :

Application Number : 214094

Patent Use Code : U-3300

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-03-09

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BEROTRALSTAT HYDROCHLORIDE

US Patent Number : 11618733

Drug Substance Claim :

Drug Product Claim :

Application Number : 214094

Patent Use Code : U-3300

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-11-01

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BEROTRALSTAT HYDROCHLORIDE

US Patent Number : 11708333

Drug Substance Claim :

Drug Product Claim :

Application Number : 214094

Patent Use Code : U-3300

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-03-09

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BIOCRYST

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BEROTRALSTAT HYDROCHLORIDE

US Patent Number : 12116346

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 214094

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-03-09

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BIOCRYST

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BEROTRALSTAT HYDROCHLORIDE

US Patent Number : 10125102

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 214094

Patent Use Code : U-3010

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-04-07

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BIOCRYST

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BEROTRALSTAT HYDROCHLORIDE

US Patent Number : 10329260

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 214094

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-03-09

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BIOCRYST

U.S.A
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BEROTRALSTAT HYDROCHLORIDE

US Patent Number : 10689346

Drug Substance Claim :

Drug Product Claim :

Application Number : 214094

Patent Use Code : U-3010

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-03-09

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BIOCRYST

U.S.A
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BEROTRALSTAT HYDROCHLORIDE

US Patent Number : 10329260

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 214094

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-03-09

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BIOCRYST

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BEROTRALSTAT HYDROCHLORIDE

US Patent Number : 10662160

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 214094

Patent Use Code : U-3010

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-11-01

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API | Excipient name

Berotralstat Hydrochloride

Synonyms

Berotralstat, 1809010-50-1, Bcx7353, Berotralstat [inn], Berotralstat [usan], Xza0kb1bdq

Cas Number

1809010-50-1

Unique Ingredient Identifier (UNII)

XZA0KB1BDQ

About Berotralstat Hydrochloride

Berotralstat is a selective inhibitor of plasma kallikrein used in the prophylaxis of attacks of hereditary angioedema (HAE). It works by blocking the enzymatic activity of plasma kallikrein in releasing bradykinin, the major biologic peptide that promotes swelling and pain associated with attacks of HAE. Developed by BioCryst Pharmaceuticals, berotralstat is taken once-daily as oral capsules. Under the market name Orladeyo, berotralstat was approved by the FDA on December 3, 2020, as the first oral, once-daily therapy to prevent angioedema attacks of HAE in adults and pediatric patients 12 years and older. In clinical trials, berotralstat was shown to significantly reduce attack rates at 24 weeks compared to placebo, which was sustained through 48 weeks. Berotralstat is strictly used to prevent, but not treat, these attacks. Previous oral therapies used for prophylaxis of HAE attacks, such as androgens, were limited by undesirable adverse effects and several contraindications. In clinical trials, berotralstat displayed a fast onset of action, long duration of action, and acceptable tolerance in patients.

Berotralstat Hydrochloride Manufacturers

A Berotralstat Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Berotralstat Hydrochloride, including repackagers and relabelers. The FDA regulates Berotralstat Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Berotralstat Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Berotralstat Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Berotralstat Hydrochloride Suppliers

A Berotralstat Hydrochloride supplier is an individual or a company that provides Berotralstat Hydrochloride active pharmaceutical ingredient (API) or Berotralstat Hydrochloride finished formulations upon request. The Berotralstat Hydrochloride suppliers may include Berotralstat Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Berotralstat Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Berotralstat Hydrochloride NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Berotralstat Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Berotralstat Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Berotralstat Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Berotralstat Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Berotralstat Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Berotralstat Hydrochloride suppliers with NDC on PharmaCompass.

Berotralstat Hydrochloride GMP

Berotralstat Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Berotralstat Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Berotralstat Hydrochloride GMP manufacturer or Berotralstat Hydrochloride GMP API supplier for your needs.

Berotralstat Hydrochloride CoA

A Berotralstat Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Berotralstat Hydrochloride's compliance with Berotralstat Hydrochloride specifications and serves as a tool for batch-level quality control.

Berotralstat Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Berotralstat Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Berotralstat Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Berotralstat Hydrochloride EP), Berotralstat Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Berotralstat Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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