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Dantrolene Sodium

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

12 API Suppliers, 8 USDMF, 6 NDC API, 6 Listed Suppliers, $ API Reference Price

12 API Suppliers
8 USDMF
6 NDC API
6 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

23 FDF Dossiers, 14 FDA Orange Book, 3 Canada, 1 Australia, 3 South Africa, 2 Listed Dossiers

23 FDF Dossiers
14 FDA Orange Book
3 Canada
1 Australia
3 South Africa
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 100MG, CAPSULE;ORAL - 25MG, CAPSULE;ORAL - 50MG

drugProductComposition
CAPSULE;ORAL - 100MG
CAPSULE;ORAL - 25MG
CAPSULE;ORAL - 50MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 15 SPI Pharma, 6 DKSH, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 3 DFE Pharma, 7 Gangwal Chemicals, 4 Ingredion Pharma Solutions, 17 Kerry, 3 Lonza Capsugel, 9 Microlex e.U, 1 Nanjing Bold Chemical, 5 Pluviaendo, 2 Prachin Chemical, 1 Qualicaps, 11 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 5 Sigachi Industries, 2 Vasa Pharmachem

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60 Fillers, Diluents & Binders, 26 Direct Compression, 16 Disintegrants & Superdisintegrants, 14 Co-Processed Excipients, 13 Chewable & Orodispersible Aids, 13 Taste Masking, 11 Solubilizers, 11 Parenteral, 10 Thickeners and Stabilizers, 10 Lubricants & Glidants, 10 Granulation, 8 Empty Capsules, 7 Coating Systems & Additives, 5 Film Formers & Plasticizers, 4 Emulsifying Agents, 3 Topical, 3 Controlled & Modified Release, 2 Coloring Agents, 2 Rheology Modifiers, 2 API Stability Enhancers, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

11 NEWS #PharmaBuzz

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11 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 3 Finished Drug Prices

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2 US Medicaid Prescriptions
3 Finished Drug Prices

MARKET PLACE

10 APIs, 6 FDF Dossiers

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10 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents

patents
1 US Patents

REF. STANDARDS & IMPURITIES

3 USP , 5 Others

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3 USP
5 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

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API REF. PRICE (USD/KG)

$ 1,174

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

6DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

4,265,785

Annual Reports (USD Million)

Finished Drug Prices

136 RELATED EXCIPIENT COMPANIES

232EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Dantrolene sodium, 14663-23-1, Tox21_500424, Ccg-221728, Ncgc00261109-01, Ac-25752

Molecular Formula

C₁₄H₉N₄NaO₅

Molecular Weight

336.23 g/mol

InChI Key

KSRLIXGNPXAZHD-HAZZGOGXSA-M

Skeletal muscle relaxant that acts by interfering with excitation-contraction coupling in the muscle fiber. It is used in spasticity and other neuromuscular abnormalities. Although the mechanism of action is probably not central, dantrolene is usually grouped with the central muscle relaxants.

1 2D Structure

Dantrolene

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;1-[(E)-[5-(4-nitrophenyl)furan-2-yl]methylideneamino]imidazolidin-3-ide-2,4-dione

2.1.2 InChI

InChI=1S/C14H10N4O5.Na/c19-13-8-17(14(20)16-13)15-7-11-5-6-12(23-11)9-1-3-10(4-2-9)18(21)22;/h1-7H,8H2,(H,16,19,20);/q;+1/p-1/b15-7+;

2.1.3 InChI Key

KSRLIXGNPXAZHD-HAZZGOGXSA-M

2.1.4 Canonical SMILES

C1C(=O)[N-]C(=O)N1N=CC2=CC=C(O2)C3=CC=C(C=C3)[N+](=O)[O-].[Na+]

2.1.5 Isomeric SMILES

C1C(=O)[N-]C(=O)N1/N=C/C2=CC=C(O2)C3=CC=C(C=C3)[N+](=O)[O-].[Na+]

2.2 Synonyms

2.2.1 MeSH Synonyms

1. Dantrium

2. Dantrolene

3. Dantrolene Sodium

4. Sodium, Dantrolene

2.2.2 Depositor-Supplied Synonyms

1. Dantrolene Sodium

2. 14663-23-1

3. Tox21_500424

4. Ccg-221728

5. Ncgc00261109-01

6. Ac-25752

7. D 9175

2.3 Create Date

2007-02-08

3 Chemical and Physical Properties

Molecular Formula	C₁₄H₉N₄NaO₅
Molecular Weight	336.23 g/mol
Hydrogen Bond Donor Count	0
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	3
Exact Mass	336.04706368 g/mol
Monoisotopic Mass	336.04706368 g/mol
Topological Polar Surface Area	110 Å²
Heavy Atom Count	24
Formal Charge	0
Complexity	530
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Dantrolene sodium
Drug Label	The chemical formula of dantrolene sodium is hydrated 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-2, 4-imidazolidinedione sodium salt. It is an orange powder, slightly soluble in water, but due to its slightly acidic nature the solubility incre...
Active Ingredient	Dantrolene sodium
Dosage Form	Capsule
Route	Oral
Strength	100mg; 25mg; 50mg
Market Status	Prescription
Company	Mikah Pharma; Impax Labs

2 of 2
Drug Name	Dantrolene sodium
Drug Label	The chemical formula of dantrolene sodium is hydrated 1-[[[5-(4-nitrophenyl)-2-furanyl]methylene]amino]-2, 4-imidazolidinedione sodium salt. It is an orange powder, slightly soluble in water, but due to its slightly acidic nature the solubility incre...
Active Ingredient	Dantrolene sodium
Dosage Form	Capsule
Route	Oral
Strength	100mg; 25mg; 50mg
Market Status	Prescription
Company	Mikah Pharma; Impax Labs

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Muscle Relaxants, Central

A heterogeneous group of drugs used to produce muscle relaxation, excepting the neuromuscular blocking agents. They have their primary clinical and therapeutic uses in the treatment of muscle spasm and immobility associated with strains, sprains, and injuries of the back and, to a lesser degree, injuries to the neck. They have been used also for the treatment of a variety of clinical conditions that have in common only the presence of skeletal muscle hyperactivity, for example, the muscle spasms that can occur in MULTIPLE SCLEROSIS. (From Smith and Reynard, Textbook of Pharmacology, 1991, p358) (See all compounds classified as Muscle Relaxants, Central.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Decreased Striated Muscle Tone [PE]; Skeletal Muscle Relaxant [EPC]; Decreased Striated Muscle Contraction [PE]

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API Reference Price

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ROAD,","city":"HYDERABAD-A.P.","supplier":"THE U.S. PHARMACOPEIAL ","supplierCountry":"INDIA","foreign_port":"WASHINGTON DULLES I","customer":"UNITED STATES PHARMACOPEIA ","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0002","unit":"KGS","unitRateFc":"2600000","totalValueFC":"546","currency":"USD","unitRateINR":"198738850","date":"08-Mar-2021","totalValueINR":"39747.77","totalValueInUsd":"546","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"3062954","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON DULLES I","supplierAddress":"","customerAddress":"106, FIRST FLOOR , ASHOKA BHOOPALCHAMBERS BEGUMPET, S.P. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1627065000,"product":"RM-5366M DANTROLENE SODIUM, MICRONIZED BORA","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"AMNEAL PHARMACEUTICALS","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"221.00","actualQuantity":"221","unit":"KGS","unitRateFc":"2231.1","totalValueFC":"498858.5","currency":"USD","unitRateINR":"168227.6","date":"24-Jul-2021","totalValueINR":"37178303","totalValueInUsd":"498858.5","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"1002855","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Micronized","supplierPort":"TAIPEI","supplierAddress":"50 HORSEBLOCK RD BROOKHAVEN,NY 11719 USA US","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1630348200,"product":"DANTROLENE SODIUM (MICRONIZED) USP","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"BIDDLE SAWYER CORPORATION","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"119.00","actualQuantity":"119","unit":"KGS","unitRateFc":"2304.8","totalValueFC":"278091","currency":"USD","unitRateINR":"173321.9","date":"31-Aug-2021","totalValueINR":"20625307","totalValueInUsd":"278091","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"1003398","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Micronized","supplierPort":"TAIPEI","supplierAddress":"505 8TH AVENUE, SUITE 1500, NEW YOR K, NY 10018, United States","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1637260200,"product":"DANTROLENE SODIUM (AS PER TEST LIC.TL\/BDZ\/21\/000264 DT.28\/10\/2021)","address":"VILLAGE THANTHEWAL ROPAR ROAD NALAGARH","city":"DISTT SOLAN","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"IMMACULE LIFESCIENCES P. LTD.","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"5760","totalValueFC":"11617.3","currency":"USD","unitRateINR":"432576","date":"19-Nov-2021","totalValueINR":"865152","totalValueInUsd":"11617.3","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"6326372","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"VILLAGE THANTHEWAL ROPAR ROAD NALAGARH"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1641148200,"product":"DANTROLENE SODIUM (MICRONIZED) USP","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"BIDDLE SAWYER CORPORATION","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"81.00","actualQuantity":"81","unit":"KGS","unitRateFc":"2376.8","totalValueFC":"194084.7","currency":"USD","unitRateINR":"178494.3","date":"03-Jan-2022","totalValueINR":"14458041","totalValueInUsd":"194084.7","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"1000022","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Micronized","supplierPort":"TAIPEI","supplierAddress":"505 8TH AVENUE, SUITE 1500, NEW YOR K, NY 10018, United States","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654194600,"product":"DANTROLENE SODIUM ITM# 3700688 CAS# 24868-20-0 BATCH NO. 70330AA133","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"BIDDLE SAWYER CORPORATION","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"31.80","actualQuantity":"31.8","unit":"KGS","unitRateFc":"2500","totalValueFC":"79993.9","currency":"USD","unitRateINR":"196250","date":"03-Jun-2022","totalValueINR":"6240750","totalValueInUsd":"79993.9","indian_port":"MADRAS AIR","hs_no":"29349990","bill_no":"8952357","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654540200,"product":"DANTROLENE SODIUM","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"101.00","actualQuantity":"101","unit":"KGS","unitRateFc":"2253","totalValueFC":"228965.3","currency":"USD","unitRateINR":"176859.3","date":"07-Jun-2022","totalValueINR":"17862793","totalValueInUsd":"228965.3","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"1002306","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1667327400,"product":"DANTROLENE SODIUM","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"89.00","actualQuantity":"89","unit":"KGS","unitRateFc":"2260.8","totalValueFC":"206850","currency":"USD","unitRateINR":"189680.7","date":"02-Nov-2022","totalValueINR":"16881582","totalValueInUsd":"206850","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"1004540","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1679250600,"product":"DANTROLENE SODIUM 3700688 LOT NO. 70330AA134 CAS.NO.24868-20-0","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"BIDDLE SAWYER CORPORATION","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"61.65","actualQuantity":"61.65","unit":"KGS","unitRateFc":"2500","totalValueFC":"156841.4","currency":"USD","unitRateINR":"209250","date":"20-Mar-2023","totalValueINR":"12900262.5","totalValueInUsd":"156841.4","indian_port":"MADRAS AIR","hs_no":"29349990","bill_no":"5138170","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1687113000,"product":"DANTROLENE SODIUM LOT NO. 70330AA137 \/ 138 CAS.NO.24868-20-0","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"BIDDLE SAWYER CORPORATION","supplierCountry":"TAIWAN","foreign_port":"NA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"90.29","actualQuantity":"90.286","unit":"KGS","unitRateFc":"2300","totalValueFC":"209814.6","currency":"USD","unitRateINR":"191015.2","date":"19-Jun-2023","totalValueINR":"17245980.51","totalValueInUsd":"209814.6","indian_port":"MADRAS AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698777000,"product":"DANTROLENE SODIUM 3700688 70330AA138 \/ 139 \/ CAS NO.24868-20-0","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"BIDDLE SAWYER CORPORATION","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"2300","totalValueFC":"174424.7","currency":"USD","unitRateINR":"193660","date":"01-Nov-2023","totalValueINR":"14524500","totalValueInUsd":"174424.7","indian_port":"Madras Air","hs_no":"29349990","bill_no":"8568658","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"505 EIGHTH AVENUE,NEW YORK NY 10018SDNF UNITED STATES","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715193000,"product":"DANTROLENE SODIUM LOT NO. 70330AA143 CAS.NO.24868-20-0","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"BIDDLE SAWYER CORPORATION","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"88.95","actualQuantity":"88.95","unit":"KGS","unitRateFc":"2250","totalValueFC":"202528.5","currency":"USD","unitRateINR":"189787.5","date":"09-May-2024","totalValueINR":"16881598.13","totalValueInUsd":"202528.5","indian_port":"Madras Air","hs_no":"29349990","bill_no":"3396890","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"505 EIGHTH AVENUE,NEW YORK NY 10018SDNF UNITED STATES","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725388200,"product":"DANTROLENE SODIUM (BATCH NO: 70330AA141) DANTROLENE SODIUM (BATCH NO: 70330AA141)","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"50.10","actualQuantity":"50.1","unit":"KGS","unitRateFc":"2250","totalValueFC":"114135.8","currency":"USD","unitRateINR":"190912.5","date":"04-Sep-2024","totalValueINR":"9564716.25","totalValueInUsd":"114135.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"5414102","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"NO.1 , NAN KE 8TH ROAD, SHAN HUA TAINAN 741014 TW","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"DANTROLENE SODIUM (BATCH NO: 70330AA141) DANTROLENE SODIUM (BATCH NO: 70330AA141)","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"KAOHSIUNG","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"50.10","actualQuantity":"50.1","unit":"KGS","unitRateFc":"2250","totalValueFC":"113963.8","currency":"USD","unitRateINR":"191137.5","date":"25-Oct-2024","totalValueINR":"9575988.75","totalValueInUsd":"113963.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29349990","bill_no":"6320496","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"KAOHSIUNG","supplierAddress":"NO.1 , NAN KE 8TH ROAD, SHAN HUA TAINAN 741014 TW","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

01 Norgine

Netherlands

BIO Partnering at JPM

Not Confirmed

02 Eagle Pharmaceuticals

U.S.A

BIO Partnering at JPM

Not Confirmed

03 Eagle Pharmaceuticals

U.S.A

BIO Partnering at JPM

Not Confirmed

04 Eagle Pharmaceuticals

U.S.A

BIO Partnering at JPM

Not Confirmed

05 University of Pennsylvania

Country

BIO Partnering at JPM

Not Confirmed

06 NorthShore University HealthSystem

Country

BIO Partnering at JPM

Not Confirmed

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FDF Dossiers

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FDA Orange Book

01

EUGIA PHARMA SPECLTS

India

BIO Partnering at JPM

Not Confirmed

02

EAGLE PHARMS

U.S.A

BIO Partnering at JPM

Not Confirmed

03

ELITE LABS INC

U.S.A

BIO Partnering at JPM

Not Confirmed

04

ELITE LABS INC

U.S.A

BIO Partnering at JPM

Not Confirmed

05

HIKMA

United Kingdom

BIO Partnering at JPM

Not Confirmed

06

IMPAX LABS

U.S.A

BIO Partnering at JPM

Not Confirmed

07

IMPAX LABS

U.S.A

BIO Partnering at JPM

Not Confirmed

08

USWM

U.S.A

BIO Partnering at JPM

Not Confirmed

09

ENDO OPERATIONS

Country

BIO Partnering at JPM

Not Confirmed

10

ENDO OPERATIONS

Country

BIO Partnering at JPM

Not Confirmed

Only 10 entries up to this point, click to access all

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Canada

01

HIKMA CANADA LIMITED

United Kingdom

Pharma, Lab & Chemical Expo

Not Confirmed

02

ENDO OPERATIONS LTD.

Country

Pharma, Lab & Chemical Expo

Not Confirmed

03

ENDO OPERATIONS LTD.

Country

Pharma, Lab & Chemical Expo

Not Confirmed

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Australia

01

Pfizer Australia Pty Ltd

Canada

Pharma, Lab & Chemical Expo

Not Confirmed

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South Africa

01

Meda Pharma South Africa (Pty) Ltd

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

02

Pharmaco Distribution (Pty) Ltd

South Africa

Pharma, Lab & Chemical Expo

Not Confirmed

03

Pharmaco Distribution (Pty) Ltd

South Africa

Pharma, Lab & Chemical Expo

Not Confirmed

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 100MG

USFDA APPLICATION NUMBER - 17443

DOSAGE - CAPSULE;ORAL - 25MG

USFDA APPLICATION NUMBER - 17443

DOSAGE - CAPSULE;ORAL - 50MG

USFDA APPLICATION NUMBER - 17443

Related Excipient Companies

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Excipients by Applications

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Fillers, Diluents & Binders

01

Rochem International Inc

U.S.A

Suppliers Night Expo

Attending

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders, Taste Masking

Brand Name : Mannitol

Application : Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

02

SPI Pharma

U.S.A

BIO Partnering at JPM

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Pharmaburst 500

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

03

SPI Pharma

U.S.A

BIO Partnering at JPM

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet

Grade : Oral

Category : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Mannogem® XL Opal

Application : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.

Pharmacopoeia Ref : NA

Technical Specs : 160 µm Powder Mannitol

Ingredient(s) : Mannitol

04

DKSH

Switzerland

CPhI WW Frankfurt

Booth #8.0P66

DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral

Grade : Parenteral, Oral

Category : Fillers, Diluents & Binders, Thickeners and Stabilizers

Brand Name : GELATIN BOVINE 140B 6M

Application : Fillers, Diluents & Binders, Thickeners and Stabilizers

Excipient Details : Gelatin bovine 140B 6M is used as a stabilizer in parenteral drug products and as a binder and filler in capsules, tablets, granules, and pellets.

Pharmacopoeia Ref : CEP, GMP, EP, USP/NF

Technical Specs : N/A

Ingredient(s) : Gelatin Excipient

05

Faran Shimi Pharmaceutical

Iran

BIO Partnering at JPM

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Lactose Monohydrate

Application : Fillers, Diluents & Binders

Excipient Details : Lactose monohydrate is widely used as a filler and diluent in solid dosage forms such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

06

Faran Shimi Pharmaceutical

Iran

BIO Partnering at JPM

Not Confirmed

Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Pregelatinized Corn Starch

Application : Fillers, Diluents & Binders

Excipient Details : Corn starch is used as a filler and binder in pharmaceutical oral solid dosage forms, including tablets.

Pharmacopoeia Ref : BP/USP

Technical Specs : NA

Ingredient(s) : Corn Starch, Pregelatinized

07

Gangwal Healthcare

India

BIO Partnering at JPM

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Thickeners and Stabilizers

Brand Name : DiCOM-DC® SP204

Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Thickeners and Stabilizers

Excipient Details : DiCOM-DC SP204 is used as a stabilizer, filler, binder, directly compressible, and co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : In-house

Technical Specs : NA

Ingredient(s) : Corn Starch, Pregelatinized

08

Gangwal Healthcare

India

BIO Partnering at JPM

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Brand Name : STARLOSE®

Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : IP/EP/USP-NF/IH

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

09

Nanjing Well Pharmaceutical

China

BIO Partnering at JPM

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Injectable / Parenteral

Grade : Parenteral

Category : Parenteral

Brand Name : Lactose Monohydrate

Application : Parenteral

Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

10

Pfanstiehl

U.S.A

BIO Partnering at JPM

Not Confirmed

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Dosage Form : Injectable / Parenteral, Tablet

Grade : Parenteral, Oral

Category : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers

Brand Name : D-Mannitol

Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers

Excipient Details : D-mannitol protects proteins from denaturation & degradation. It is also used as a stabilizer in liquid formulations & as a bulking agent in tablets.

Pharmacopoeia Ref : USP, NF, EP, JP, ChP

Technical Specs : N/A

Ingredient(s) : Mannitol

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Direct Compression

Disintegrants & Superdisintegrants

Co-Processed Excipients

Chewable & Orodispersible Aids

Taste Masking

Solubilizers

Parenteral

Thickeners and Stabilizers

Lubricants & Glidants

Granulation

Empty Capsules

Coating Systems & Additives

Film Formers & Plasticizers

Emulsifying Agents

Topical

Controlled & Modified Release

Coloring Agents

Rheology Modifiers

API Stability Enhancers

Surfactant & Foaming Agents

Digital Content

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NEWS #PharmaBuzz

Global Sales Information

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US Medicaid Prescriptions

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Finished Drug Prices

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Market Place

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APIs

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FDF DOSSIERS

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Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

01

EAGLE PHARMS

DANTROLENE SODIUM

Biotech Showcase

Not Confirmed

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REF. STANDARDS & IMPURITIES

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USP

Others

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Dantrolene Sodium Manufacturers

A Dantrolene Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dantrolene Sodium, including repackagers and relabelers. The FDA regulates Dantrolene Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dantrolene Sodium 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 Dantrolene Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Dantrolene Sodium Suppliers

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

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

Dantrolene Sodium USDMF

A Dantrolene Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Dantrolene Sodium active pharmaceutical ingredient (API) in detail. Different forms of Dantrolene Sodium DMFs exist exist since differing nations have different regulations, such as Dantrolene Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Dantrolene Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Dantrolene Sodium USDMF includes data on Dantrolene Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dantrolene Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Dantrolene Sodium suppliers with USDMF on PharmaCompass.

Dantrolene Sodium 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 Dantrolene Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Dantrolene Sodium 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 Dantrolene Sodium 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 Dantrolene Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dantrolene Sodium NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Dantrolene Sodium suppliers with NDC on PharmaCompass.

Dantrolene Sodium GMP

Dantrolene Sodium 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 Dantrolene Sodium 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 Dantrolene Sodium GMP manufacturer or Dantrolene Sodium GMP API supplier for your needs.

Dantrolene Sodium CoA

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

Dantrolene Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Dantrolene Sodium 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.

Dantrolene Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Dantrolene Sodium EP), Dantrolene Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dantrolene Sodium 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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ACTIVE PHARMA INGREDIENTS

12 API Suppliers

8 USDMF

6 NDC API

6 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

23 FDF Dossiers

14 FDA Orange Book

3 Canada

1 Australia

3 South Africa

2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 100MG

CAPSULE;ORAL - 25MG

CAPSULE;ORAL - 50MG

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60 Fillers, Diluents & Binders

26 Direct Compression

16 Disintegrants & Superdisintegrants

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11 Solubilizers

11 Parenteral

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8 Empty Capsules

7 Coating Systems & Additives

5 Film Formers & Plasticizers

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