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Sapropterin Hydrochloride

Biophore Sapropterin HCl

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

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

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

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

FINISHED DOSAGE FORMULATIONS

49 FDF Dossiers, 12 FDA Orange Book, 20 Europe, 5 Canada, 11 Australia, 1 Listed Dossiers

49 FDF Dossiers
12 FDA Orange Book
20 Europe
5 Canada
11 Australia
1 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 13 SPI Pharma, 1 Pharm-RX Chemical, 2 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 2 Gangwal Healthcare, 1 Pfanstiehl, 2 Alcedo Pharmachem, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 1 Bioplus Life Sciences, 5 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 Kerry, 3 Microlex e.U, 1 NEWEDGE Overseas, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 1 Prachin Chemical, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 1 Ulanqab Kema New Material

EXCIPIENTS BY APPLICATIONS

21 Fillers, Diluents & Binders, 17 Direct Compression, 17 Disintegrants & Superdisintegrants, 14 Chewable & Orodispersible Aids, 11 Taste Masking, 7 Granulation, 6 Lubricants & Glidants, 5 Thickeners and Stabilizers, 4 Co-Processed Excipients, 4 Parenteral, 3 Solubilizers, 2 Coating Systems & Additives, 1 API Stability Enhancers, 1 Film Formers & Plasticizers

excipientsByApplications
21 Fillers, Diluents & Binders
17 Direct Compression
17 Disintegrants & Superdisintegrants
14 Chewable & Orodispersible Aids
11 Taste Masking
7 Granulation
6 Lubricants & Glidants
5 Thickeners and Stabilizers
4 Co-Processed Excipients
4 Parenteral
3 Solubilizers
2 Coating Systems & Additives
1 API Stability Enhancers
1 Film Formers & Plasticizers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 33 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
33 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 19 Finished Drug Prices, 7 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
19 Finished Drug Prices
7 Annual Reports

MARKET PLACE

15 APIs, 1 FDF Dossiers, 1 Intermediates

marketPlace
15 APIs
1 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

42 US Patents, 4 Health Canada Patents

patents
42 US Patents
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

8 Others

otherSolutions
8 Others

Sapropterin HCl

Synopsis

ACTIVE PHARMA INGREDIENTS

12

API Suppliers

8

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

0

EU WC

0

KDMF

8

NDC API

0

VMF

6

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 16,584

MARKET PLACE

15

API

1

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

49

FDF Dossiers

12

FDA Orange Book

FDA (Orange Book)

20

Europe

5

Canada

11

Australia

0

South Africa

1

Listed Dossiers

4DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

8

Others

PATENTS & EXCLUSIVITIES

42

US Patents

0

US Exclusivities

4

Health Canada Patents

DIGITAL CONTENT

1

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

33

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

25,936,530

Annual Reports (USD Million)

2,458

Finished Drug Prices

63 RELATED EXCIPIENT COMPANIES

113EXCIPIENTS BY APPLICATIONS

Chemistry

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Click the button for full data set

Click the button for full data set

Also known as:

Molecular Formula

C₉H₁₇Cl₂N₅O₃

Molecular Weight

314.17 g/mol

InChI Key

RKSUYBCOVNCALL-NTVURLEBSA-N

Sapropterin Hydrochloride

1 2D Structure

Sapropterin Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-1H-pteridin-4-one;dihydrochloride

2.1.2 InChI

InChI=1S/C9H15N5O3.2ClH/c1-3(15)6(16)4-2-11-7-5(12-4)8(17)14-9(10)13-7;;/h3-4,6,12,15-16H,2H2,1H3,(H4,10,11,13,14,17);2*1H/t3-,4+,6-;;/m0../s1

2.1.3 InChI Key

RKSUYBCOVNCALL-NTVURLEBSA-N

2.1.4 Canonical SMILES

CC(C(C1CNC2=C(N1)C(=O)N=C(N2)N)O)O.Cl.Cl

2.1.5 Isomeric SMILES

C[C@@H]([C@@H]([C@H]1CNC2=C(N1)C(=O)N=C(N2)N)O)O.Cl.Cl

2.2 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₉H₁₇Cl₂N₅O₃
Molecular Weight	314.17 g/mol
Hydrogen Bond Donor Count	8
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	2
Exact Mass	313.0708448 g/mol
Monoisotopic Mass	313.0708448 g/mol
Topological Polar Surface Area	132 A^2
Heavy Atom Count	19
Formal Charge	0
Complexity	405
Isotope Atom Count	0
Defined Atom Stereocenter Count	3
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

API SUPPLIERS

01

Biophore India Pharmaceuticals Pvt...

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Contact Supplier

Contact Supplier

India

Digital Content

USDMF

Click Us!

CEP/COS JDMF EU-WC NDC

KDMF VMF Others AUDIT

Product Web Link

Digital Content

02

HONOUR LAB LTD

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

DDL Conference

Not Confirmed

03

Asymchem Laboratories

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

DDL Conference

Not Confirmed

04

Innopharmax

Taiwan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

DDL Conference

Not Confirmed

05

Dipharma SA

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

DDL Conference

Not Confirmed

06

Dipharma

Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

DDL Conference

Not Confirmed

07

Solara Active Pharma Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

DDL Conference

Not Confirmed

08

Shiratori Pharmaceutical

Japan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

DDL Conference

Not Confirmed

09

Seven Star Pharmaceutical

Taiwan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

DDL Conference

Not Confirmed

10

Maithri Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

DDL Conference

Not Confirmed

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USDMF

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NDC API

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Listed Suppliers

01

Biophore India Pharmaceuticals Pvt ...

India

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Contact Supplier

Contact Supplier

India

Digital Content

Sapropterin Hydrochloride

About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

Product Web Link

Digital Content

02

Hetero Drugs

India

Antibody Engineering

Not Confirmed

03

Maithri Drugs

India

Antibody Engineering

Not Confirmed

04

Mehta API

India

Antibody Engineering

Not Confirmed

05

Seven Star Pharmaceutical

Taiwan

Antibody Engineering

Not Confirmed

06

Solara Active Pharma Sciences

India

Antibody Engineering

Not Confirmed

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API Reference Price

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Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1668018600,"product":"SAPROPTERINE DIHYDROCHLORIDE API D01APIM2M9 BATCHNO. 2212209\/ 2212286","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"NA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"99.60","actualQuantity":"99.6","unit":"KGS","unitRateFc":"37500","totalValueFC":"3835103.2","currency":"USD","unitRateINR":"3142500","date":"10-Nov-2022","totalValueINR":"312993000","totalValueInUsd":"3835103.2","indian_port":"MADRAS AIR","hs_no":"29339990","bill_no":"3238178","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674066600,"product":"SAPROPTERINE API D01APIM2M9 BATCH NO.2300040","address":"No. 9\/215, Pudupakkam - 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Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1681669800,"product":"SAPROPTERINE DIHYDROCHLORIDE API D01APIM2M9 BATCH NO.2303852","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"NA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"49.00","actualQuantity":"49","unit":"KGS","unitRateFc":"37500","totalValueFC":"1857594.3","currency":"USD","unitRateINR":"3106875","date":"17-Apr-2023","totalValueINR":"152236875","totalValueInUsd":"1857594.3","indian_port":"MADRAS AIR","hs_no":"29339990","bill_no":"5545436","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683138600,"product":"SAPROPTERIN API 40 KG MERETO 300 (IGST EXEMPTED AS PER GST NOTIFICATION NO. 64\/2017)","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"15675","totalValueFC":"158399.3","currency":"USD","unitRateINR":"1303376.3","date":"04-May-2023","totalValueINR":"13033763","totalValueInUsd":"158399.3","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29335990","bill_no":"1000218","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"PIAZZA COL. C.BERNASCONI 5 6830 - CHIASSO SWITZERLAND","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1685903400,"product":"SAPROPTERIN API 40 KG MERETO 300 (IGST EXEMPTED AS PER GST NOTIFICATION NO. 64\/2017)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"XXPHAXXA SX","supplierCountry":"KUWAIT","foreign_port":"SHUWAIKH","customer":"DR. 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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"15000","totalValueFC":"303167.2","currency":"USD","unitRateINR":"1262250","date":"06-Nov-2023","totalValueINR":"25245000","totalValueInUsd":"303167.2","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29335990","bill_no":"1000574","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"KUWAIT","selfForZScoreResived":"Pharma Grade","supplierPort":"SHUWAIKH","supplierAddress":"N\/A","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701455400,"product":"SAPROPTERINE API D01APIM2M9 BATCH NO.2313414","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"46.70","actualQuantity":"46.7","unit":"KGS","unitRateFc":"37500","totalValueFC":"1769276.1","currency":"USD","unitRateINR":"3153750","date":"02-Dec-2023","totalValueINR":"147280125","totalValueInUsd":"1769276.1","indian_port":"Madras Air","hs_no":"29349990","bill_no":"9039562","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"PIAZZA COL. 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C.BERNASCONI 5 6830 - CHIASSO SWITZERLAND","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711391400,"product":"SAPROPTERIN API 17 KG AMINO 300 (IGST EXEMPTED AS PER GST NOTIFICATION NO. 64\/2017)","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DIPHARMA","supplierCountry":"MALTA","foreign_port":"MALTA (VALLETTA)","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"19.00","actualQuantity":"19","unit":"KGS","unitRateFc":"14602.8","totalValueFC":"280340.7","currency":"USD","unitRateINR":"1225174.4","date":"26-Mar-2024","totalValueINR":"23278313","totalValueInUsd":"280340.7","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29335990","bill_no":"1000163","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA (VALLETTA)","supplierAddress":"PIAZZA COL. C.BERNASCONI 5 6830 - CHIASSO SWITZERLAND","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713378600,"product":"SAPROPTERINE DIHYDROCHLORIDE (API)","address":"221, GOREGAON-MULUND LINK ROAD,","city":"BHANDUP WEST, MUMBAI","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"RUBICON RESEARCH","customerCountry":"INDIA","quantity":"24.00","actualQuantity":"24","unit":"KGS","unitRateFc":"7121.5","totalValueFC":"188400","currency":"EUR","unitRateINR":"655532.2","date":"18-Apr-2024","totalValueINR":"15732773.62","totalValueInUsd":"188400","indian_port":"Bombay Air","hs_no":"29242990","bill_no":"3084448","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIA BISSONE 520021 BARANZATE MIITALY IT","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719253800,"product":"SAPROPTERINE API D01APIM2M9 BATCH NO.2407034","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"44.50","actualQuantity":"44.5","unit":"KGS","unitRateFc":"37500","totalValueFC":"1685153.3","currency":"USD","unitRateINR":"3161250","date":"25-Jun-2024","totalValueINR":"140675625","totalValueInUsd":"1685153.3","indian_port":"Madras Air","hs_no":"29339990","bill_no":"4176793","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"PIAZZA COL. C.BERNASCONI 56830 - CHIASSOSDNF SWITZERLAND","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"SAPROPTERIN API 40 KG MERETO 300","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"MALPENSA APT\/MILANO","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"18.40","actualQuantity":"18.4","unit":"KGS","unitRateFc":"15000","totalValueFC":"279033.2","currency":"USD","unitRateINR":"1274250","date":"28-Oct-2024","totalValueINR":"23446200","totalValueInUsd":"279033.2","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29335990","bill_no":"6381049","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"Piazza Col. C. Bernasconi 5 Chiasso SDNF Switzerland","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"SAPROPTERIN API 40 KG MERETO 300","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"DIPHARMA","supplierCountry":"ITALY","foreign_port":"MALPENSA APT\/MILANO","customer":"DR. REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"49.70","actualQuantity":"49.7","unit":"KGS","unitRateFc":"15000","totalValueFC":"753693","currency":"USD","unitRateINR":"1274250","date":"28-Oct-2024","totalValueINR":"63330225","totalValueInUsd":"753693","indian_port":"Reddy r-SEZ\/Srikakulam","hs_no":"29335990","bill_no":"6381049","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MALPENSA APT\/MILANO","supplierAddress":"Piazza Col. C. Bernasconi 5 Chiasso SDNF Switzerland","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"}]

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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FDA Orange Book

01

DR REDDYS

India

Antibody Engineering

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Contact Supplier

India

Digital Content

RLD : No

TE Code : AB

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2021-06-15

Application Number : 207685

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Product Web Link

Digital Content

02

DR REDDYS

India

Antibody Engineering

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Contact Supplier

India

Digital Content

RLD : No

TE Code : AB

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : POWDER;ORAL

Dosage Strength : 100MG/PACKET

Approval Date : 2021-03-30

Application Number : 209452

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Product Web Link

Digital Content

03

DR REDDYS

India

Antibody Engineering

Not Confirmed

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Contact Supplier

India

Digital Content

RLD : No

TE Code : AB

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : POWDER;ORAL

Dosage Strength : 500MG/PACKET

Approval Date : 2022-05-13

Application Number : 215798

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Product Web Link

Digital Content

04

ANNORA PHARMA

India

Antibody Engineering

Not Confirmed

05

ANNORA PHARMA

India

Antibody Engineering

Not Confirmed

06

ANNORA PHARMA

India

Antibody Engineering

Not Confirmed

07

BIOMARIN PHARM

U.S.A

Antibody Engineering

Not Confirmed

08

BIOMARIN PHARM

U.S.A

Antibody Engineering

Not Confirmed

09

BIOMARIN PHARM

U.S.A

Antibody Engineering

Not Confirmed

10

ENDO OPERATIONS

Country

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Europe

01

AUROBINDO PHARMA ITALIA SRL

India

Antibody Engineering

Not Confirmed

02

BioMarin International Limited

U.S.A

Antibody Engineering

Not Confirmed

03

BioMarin International Limited

U.S.A

Antibody Engineering

Not Confirmed

04

BIOMARIN INTERNATIONAL LIMITED

U.S.A

Antibody Engineering

Not Confirmed

05

DIPHARMA ARZNEIMITTEL GMBH

Italy

Antibody Engineering

Not Confirmed

06

Dipharma Arzneimittel GmbH

Italy

Antibody Engineering

Not Confirmed

07

Dipharma Arzneimittel GmbH

Italy

Antibody Engineering

Not Confirmed

08

Dipharma SA

Switzerland

Antibody Engineering

Not Confirmed

09

Dipharma SA

Switzerland

Antibody Engineering

Not Confirmed

10

Dipharma SA

Switzerland

Antibody Engineering

Not Confirmed

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Canada

01

BIOMARIN INTERNATIONAL LIMITED

U.S.A

Antibody Engineering

Not Confirmed

02

BIOMARIN INTERNATIONAL LIMITED

U.S.A

Antibody Engineering

Not Confirmed

03

BIOMARIN INTERNATIONAL LIMITED

U.S.A

Antibody Engineering

Not Confirmed

04

DR REDDY'S LABORATORIES LTD

Country

Antibody Engineering

Not Confirmed

05

DR REDDY'S LABORATORIES LTD

Country

Antibody Engineering

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Australia

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Listed Dossiers

01

Dipharma Francis S.r.l

Italy

Antibody Engineering

Not Confirmed

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Finished Drug Prices

01

Brand Name : Sapropterin Dipharma

Switzerland

Antibody Engineering

Not Confirmed

02

Brand Name : Sapropterin Dipharma

Switzerland

Antibody Engineering

Not Confirmed

03

Brand Name : Sapropterin Dipharma

Switzerland

Antibody Engineering

Not Confirmed

04

Brand Name : Sapropterin Dipharma

Switzerland

Antibody Engineering

Not Confirmed

05

Brand Name : SAPROPTERIN DIPHARMA

Italy

Antibody Engineering

Not Confirmed

06

Brand Name : Sapropterin Dipharma

Italy

Antibody Engineering

Not Confirmed

07

Brand Name : Sapropterin Dipharma

Italy

Antibody Engineering

Not Confirmed

08

Brand Name : Kuvan

U.S.A

Antibody Engineering

Not Confirmed

09

Brand Name : Sapropterin Dipharma

Italy

Antibody Engineering

Not Confirmed

10

Brand Name : Kuvan

Country

Antibody Engineering

Not Confirmed

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Annual Reports

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APIs

Sapropterin HCl API needed in Algeria [ENA20989]

A large pharmaceutical manufacturing and distribution company that deals in 14 therapeutic classes is looking for suppliers of Sapropterin HCl API. The initial required quantity is 5 kg and later 20 kg for commercial purposes. The suppliers must support this enquiry with DMF & CoA.

Reply

29 Oct 2024

Sapropterin Dihydrochloride API needed in India [ENA18412]

A company that focuses on research, development and manufacturing of OSDs, semi-solids & parenteral is looking for suppliers of Sapropterin Dihydrochloride API for development purposes. The suppliers must support this enquiry with CoA.

Reply

20 Oct 2023

Sapropterin HCl (1 kg) API needed in Egypt [ENA17140]

A pharmaceutical company based in Egypt is looking for suppliers of Sapropterin HCl (1 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

Reply

22 May 2023

Sapropterin HCl API needed in Egypt [ENA16613]

A company that deals in various pharmaceutical products is looking for suppliers of Sapropterin HCl API for commercial purposes. The suppliers must support this enquiry with CoA.

Reply

15 Mar 2023

USP Grade Sapropterin Dihydrochloride (20 kg) API needed in Iran [ENA14058]

A company that deals in various pharmaceutical products is looking for suppliers of USP Grade Sapropterin Dihydrochloride (20 kg) API for commercial purpose. The suppliers must support this enquiry with CoA.

Reply

22 Jun 2022

Various APIs needed in India [ENA11999]

A company that deals in the development & manufacturing of various pharmaceutical products is looking for suppliers of Various APIs for development purpose. The required quantity is 50 g - 100 g for each. The suppliers must support this enquiry with GMP & CoA. 1. Favipiravir API 2. Tacrolimus API 3. Mupirocin API 4. Sapropterin HCl API

Reply

03 Dec 2021

Sapropterin Dihydrochloride API needed in Greece [ENA09495]

A Swiss multinational medical company that aims to provide the most innovative and reliable solutions is looking for suppliers of Sapropterin Dihydrochloride API for development purposes. The final market is the EU market.

Reply

14 Jan 2021

Sapropterin API needed in the US [ENA08941]

A technology-based product company focusing on the development and commercialization of branded specialty products is looking for suppliers of Sapropterin API.

Reply

30 Oct 2020

Various APIs needed in Turkey [ENA07525]

A pharmaceutical manufacturing company that deals in various dosage forms such as solids, liquids, semi-solids, soft gel capsules & also hormonal medicines is looking for suppliers of Various APIs. The suppliers must support this enquiry with DMF & GMP. 1. Nitisinone 2. Riociguat 3. Sapropterin 4. Trandolapril 5. Verapamil HCl

Reply

09 Jun 2020

Various APIs needed in Turkey [ENA06883]

A company engaged in the development, production, and sales of pharmaceutical products in more than 35 countries worldwide is looking for Various APIs: 1. Gadobutrol Anhydrous 2. Gadolinium Oxide Injectable grade with BET 3. Netarsudil Dimesylate 4. Baloxavir Marboxil 5. Peramivir 6. Ripasudil HCl Hydrate 7. Semaglutide 8. Rebamipide Sterile 9. Meglumine Antimonate 10. Brivaracetam 11. Cangrelor Tetrasodium 12. Urapidil HCl Injectable grade with BET 13. Fondaparinux Sodium 14. Sapropterin HCl 15. Dapagliflozin Propylene Glycolate Hydrate

Reply

19 Mar 2020

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FDF DOSSIERS

Levetiracetam Syrup & Sapropterin HCl Tablets needed in Italy [ENA10201]

A company that deals in pharmaceutical and medical food areas, offering twofold expertise with a high degree of specialization and diverse therapeutic treatments is looking for suppliers of Levetiracetam (100 mg/ ml in 150 ml and 300 ml) Syrup & Sapropterin HCl (100 mg) Tablets for commercial purposes. The required quantity for Sapropterin HCl is MOQ and Levetiracetam is 130,000 units/ 3 years. The Dossiers needs to be in EU format.

Reply

13 Apr 2021

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INTERMEDIATES

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Patents & EXCLUSIVITIES

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US Patents

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Health Canada Patents

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REF. STANDARDS & IMPURITIES

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Others

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