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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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VMF

NDC API

API REF. PRICE (USD/KG)

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FINISHED DOSAGE FORMULATIONS

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Europe

Europe

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Canada

Canada

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South Africa

South Africa

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USP

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PATENTS & EXCLUSIVITIES

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Health Canada Patents

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Stock Recap #PipelineProspector

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GLOBAL SALES INFORMATION

Finished Drug Prices

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9 RELATED EXCIPIENT COMPANIES

8EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Gtpl9416, Isis396443
Molecular Formula
C234H340N61O128P17S17
Molecular Weight
7127  g/mol
InChI Key
WWFDJIVIDXJAQR-FFWSQMGZSA-N

Nusinersen Sodium
1 2D Structure

Nusinersen Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-[(2R,3R,4R,5R)-4-[[(2R,3R,4R,5R)-5-(4-amino-5-methyl-2-oxopyrimidin-1-yl)-3-[[(2R,3R,4R,5R)-3-[[(2R,3R,4R,5R)-5-(4-amino-5-methyl-2-oxopyrimidin-1-yl)-3-[[(2R,3R,4R,5R)-3-[[(2R,3R,4R,5R)-3-[[(2R,3R,4R,5R)-3-[[(2R,3R,4R,5R)-5-(4-amino-5-methyl-2-oxopyrimidin-1-yl)-3-[[(2R,3R,4R,5R)-3-[[(2R,3R,4R,5R)-3-[[(2R,3R,4R,5R)-3-[[(2R,3R,4R,5R)-3-[[(2R,3R,4R,5R)-3-[[(2R,3R,4R,5R)-3-[[(2R,3R,4R,5R)-5-(4-amino-5-methyl-2-oxopyrimidin-1-yl)-3-[[(2R,3R,4R,5R)-3-[[(2R,3R,4R,5R)-5-(2-amino-6-oxo-1H-purin-9-yl)-3-[[(2R,3R,4R,5R)-5-(2-amino-6-oxo-1H-purin-9-yl)-3-hydroxy-4-(2-methoxyethoxy)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-4-(2-methoxyethoxy)oxolan-2-yl]methoxy-sulfanylphosphoryl]oxy-4-(2-methoxyethoxy)-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-4-(2-methoxyethoxy)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-5-(2-amino-6-oxo-1H-purin-9-yl)-4-(2-methoxyethoxy)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-4-(2-methoxyethoxy)-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-5-(6-aminopurin-9-yl)-4-(2-methoxyethoxy)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-5-(6-aminopurin-9-yl)-4-(2-methoxyethoxy)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-4-(2-methoxyethoxy)-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-5-(6-aminopurin-9-yl)-4-(2-methoxyethoxy)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-4-(2-methoxyethoxy)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-4-(2-methoxyethoxy)-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-4-(2-methoxyethoxy)-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-4-(2-methoxyethoxy)-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-4-(2-methoxyethoxy)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-5-(6-aminopurin-9-yl)-4-(2-methoxyethoxy)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-4-(2-methoxyethoxy)oxolan-2-yl]methoxy-hydroxyphosphinothioyl]oxy-5-(hydroxymethyl)-3-(2-methoxyethoxy)oxolan-2-yl]-5-methylpyrimidine-2,4-dione
2.1.2 InChI
InChI=1S/C234H340N61O128P17S17/c1-106-66-278(224(308)261-178(106)235)205-162(356-50-32-338-14)144(119(391-205)79-373-425(320,442)407-143-117(77-296)389-204(161(143)355-49-31-337-13)282-70-110(5)193(298)271-228(282)312)410-431(326,448)383-89-129-154(172(366-60-42-348-24)215(401-129)289-99-254-135-182(239)246-95-250-186(135)289)419-436(331,453)379-81-121-145(163(357-51-33-339-15)206(393-121)279-67-107(2)179(236)262-225(279)309)408-426(321,443)375-83-123-149(167(361-55-37-343-19)210(395-123)284-72-112(7)195(300)273-230(284)314)413-429(324,446)378-86-125-150(168(362-56-38-344-20)211(397-125)285-73-113(8)196(301)274-231(285)315)414-430(325,447)377-85-124-148(166(360-54-36-342-18)209(396-124)283-71-111(6)194(299)272-229(283)313)412-428(323,445)374-80-120-147(165(359-53-35-341-17)208(392-120)281-69-109(4)181(238)264-227(281)311)411-432(327,449)384-90-130-155(173(367-61-43-349-25)216(402-130)290-100-255-136-183(240)247-96-251-187(136)290)420-437(332,454)381-87-127-152(170(364-58-40-346-22)213(399-127)287-75-115(10)198(303)276-233(287)317)415-433(328,450)385-91-131-157(175(369-63-45-351-27)218(403-131)292-102-257-138-185(242)249-98-253-189(138)292)422-440(335,457)386-92-132-156(174(368-62-44-350-26)217(404-132)291-101-256-137-184(241)248-97-252-188(137)291)421-438(333,455)382-88-128-153(171(365-59-41-347-23)214(400-128)288-76-116(11)199(304)277-234(288)318)417-435(330,452)388-94-134-159(177(371-65-47-353-29)220(406-134)295-105-260-141-192(295)267-223(245)270-202(141)307)423-439(334,456)380-82-122-146(164(358-52-34-340-16)207(394-122)280-68-108(3)180(237)263-226(280)310)409-427(322,444)376-84-126-151(169(363-57-39-345-21)212(398-126)286-74-114(9)197(302)275-232(286)316)416-434(329,451)387-93-133-158(176(370-64-46-352-28)219(405-133)294-104-259-140-191(294)266-222(244)269-201(140)306)418-424(319,441)372-78-118-142(297)160(354-48-30-336-12)203(390-118)293-103-258-139-190(293)265-221(243)268-200(139)305/h66-76,95-105,117-134,142-177,203-220,296-297H,30-65,77-94H2,1-29H3,(H,319,441)(H,320,442)(H,321,443)(H,322,444)(H,323,445)(H,324,446)(H,325,447)(H,326,448)(H,327,449)(H,328,450)(H,329,451)(H,330,452)(H,331,453)(H,332,454)(H,333,455)(H,334,456)(H,335,457)(H2,235,261,308)(H2,236,262,309)(H2,237,263,310)(H2,238,264,311)(H2,239,246,250)(H2,240,247,251)(H2,241,248,252)(H2,242,249,253)(H,271,298,312)(H,272,299,313)(H,273,300,314)(H,274,301,315)(H,275,302,316)(H,276,303,317)(H,277,304,318)(H3,243,265,268,305)(H3,244,266,269,306)(H3,245,267,270,307)/t117-,118-,119-,120-,121-,122-,123-,124-,125-,126-,127-,128-,129-,130-,131-,132-,133-,134-,142-,143-,144-,145-,146-,147-,148-,149-,150-,151-,152-,153-,154-,155-,156-,157-,158-,159-,160-,161-,162-,163-,164-,165-,166-,167-,168-,169-,170-,171-,172-,173-,174-,175-,176-,177-,203-,204-,205-,206-,207-,208-,209-,210-,211-,212-,213-,214-,215-,216-,217-,218-,219-,220-,424?,425?,426?,427?,428?,429?,430?,431?,432?,433?,434?,435?,436?,437?,438?,439?,440?/m1/s1
2.1.3 InChI Key
WWFDJIVIDXJAQR-FFWSQMGZSA-N
2.1.4 Canonical SMILES
CC1=CN(C(=O)NC1=O)C2C(C(C(O2)CO)OP(=S)(O)OCC3C(C(C(O3)N4C=C(C(=NC4=O)N)C)OCCOC)OP(=S)(O)OCC5C(C(C(O5)N6C=NC7=C(N=CN=C76)N)OCCOC)OP(=S)(O)OCC8C(C(C(O8)N9C=C(C(=NC9=O)N)C)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=C(C(=O)NC1=O)C)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=C(C(=O)NC1=O)C)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=C(C(=O)NC1=O)C)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=C(C(=NC1=O)N)C)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=NC2=C(N=CN=C21)N)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=C(C(=O)NC1=O)C)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=NC2=C(N=CN=C21)N)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=NC2=C(N=CN=C21)N)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=C(C(=O)NC1=O)C)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=NC2=C1N=C(NC2=O)N)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=C(C(=NC1=O)N)C)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=C(C(=O)NC1=O)C)OCCOC)OP(=O)(OCC1C(C(C(O1)N1C=NC2=C1N=C(NC2=O)N)OCCOC)OP(=S)(O)OCC1C(C(C(O1)N1C=NC2=C1N=C(NC2=O)N)OCCOC)O)S)OCCOC
2.1.5 Isomeric SMILES
CC1=CN(C(=O)NC1=O)[C@H]2[C@@H]([C@@H]([C@H](O2)CO)OP(=S)(O)OC[C@@H]3[C@H]([C@H]([C@@H](O3)N4C=C(C(=NC4=O)N)C)OCCOC)OP(=S)(O)OC[C@@H]5[C@H]([C@H]([C@@H](O5)N6C=NC7=C(N=CN=C76)N)OCCOC)OP(=S)(O)OC[C@@H]8[C@H]([C@H]([C@@H](O8)N9C=C(C(=NC9=O)N)C)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=C(C(=O)NC1=O)C)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=C(C(=O)NC1=O)C)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=C(C(=O)NC1=O)C)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=C(C(=NC1=O)N)C)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=NC2=C(N=CN=C21)N)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=C(C(=O)NC1=O)C)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=NC2=C(N=CN=C21)N)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=NC2=C(N=CN=C21)N)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=C(C(=O)NC1=O)C)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=NC2=C1N=C(NC2=O)N)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=C(C(=NC1=O)N)C)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=C(C(=O)NC1=O)C)OCCOC)OP(=O)(OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=NC2=C1N=C(NC2=O)N)OCCOC)OP(=S)(O)OC[C@@H]1[C@H]([C@H]([C@@H](O1)N1C=NC2=C1N=C(NC2=O)N)OCCOC)O)S)OCCOC
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Gtpl9416

2. Isis396443

2.3 Create Date
2017-01-30
3 Chemical and Physical Properties
Molecular Weight 7127 g/mol
Molecular Formula C234H340N61O128P17S17
XLogP3-14.4
Hydrogen Bond Donor Count40
Hydrogen Bond Acceptor Count167
Rotatable Bond Count176
Exact Mass7124.2829700 g/mol
Monoisotopic Mass7122.2762603 g/mol
Topological Polar Surface Area2820 Ų
Heavy Atom Count457
Formal Charge0
Complexity19100
Isotope Atom Count0
Defined Atom Stereocenter Count72
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 1  
Drug NameSPINRAZA
Active IngredientNUSINERSEN SODIUM
CompanyBIOGEN IDEC (Application Number: N209531. Patents: 6166197, 6210892, 7101993, 7838657, 8110560, 8361977, 8980853)

API SUPPLIERS

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01

Transo-Pharm USA LLC

U.S.A

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

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Virtual BoothTransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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Anhui Ribobay Pharmaceutical Co.,L...

China

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

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PharmaVenue
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Virtual BoothRibobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.

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03

Omgene Life Sciences Pvt. Ltd

India

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

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Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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TAPI Technology & API Services

Israel

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

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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Jiangsu Sinopep Allsino Biopharmac...

China

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API Reference Price

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[{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734633000,"product":"NUSINERSEN NUSINERSEN","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"HANGZHOU APEXTIDE BIOMEDICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"1.32","unit":"GMS","unitRateFc":"2221","totalValueFC":"2965.5","currency":"USD","unitRateINR":"190891.7","date":"20-Dec-2024","totalValueINR":"251977.03","totalValueInUsd":"2965.5","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"7350163","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"TECHNOLOGY CO., LTD BUILDING 14, YINHAI KECHUANG CENTER NO.501 FUCHENG ROAD, XIASHA STREET CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735237800,"product":"NUSINERSEN NUSINERSEN","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"HANGZHOU APEXTIDE BIOMEDICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"7.16","unit":"GMS","unitRateFc":"237.4","totalValueFC":"1719.6","currency":"USD","unitRateINR":"20407.1","date":"27-Dec-2024","totalValueINR":"146115","totalValueInUsd":"1719.6","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"7489295","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"TECHNOLOGY CO., LTD BUILDING 14, YINHAI KECHUANG CENTER NO.501 FUCHENG ROAD, XIASHA STREET CHINA","customerAddress":"MUMBAI CENTRAL,"}]
20-Dec-2024
27-Dec-2024
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Patents & EXCLUSIVITIES

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US Patents

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01

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BIO Partnering at JPM
Not Confirmed

BIOGEN IDEC

U.S.A
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BIO Partnering at JPM
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NUSINERSEN SODIUM

US Patent Number : 12013403

Drug Substance Claim :

Drug Product Claim :

Application Number : 209531

Patent Use Code : U-2093

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-03-04

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02

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BIO Partnering at JPM
Not Confirmed

BIOGEN IDEC

U.S.A
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BIO Partnering at JPM
Not Confirmed

NUSINERSEN SODIUM

US Patent Number : 10436802

Drug Substance Claim :

Drug Product Claim :

Application Number : 209531

Patent Use Code : U-1944

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-09-11

blank

03

arrow
BIO Partnering at JPM
Not Confirmed

BIOGEN IDEC

U.S.A
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BIO Partnering at JPM
Not Confirmed

NUSINERSEN SODIUM

US Patent Number : 10266822

Drug Substance Claim :

Drug Product Claim :

Application Number : 209531

Patent Use Code : U-1944

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-12-05

blank

04

arrow
BIO Partnering at JPM
Not Confirmed

BIOGEN IDEC

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

NUSINERSEN SODIUM

US Patent Number : 12013403

Drug Substance Claim :

Drug Product Claim :

Application Number : 209531

Patent Use Code : U-2094

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-03-04

blank

05

arrow
BIO Partnering at JPM
Not Confirmed

BIOGEN IDEC

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

NUSINERSEN SODIUM

US Patent Number : 10436802

Drug Substance Claim :

Drug Product Claim :

Application Number : 209531

Patent Use Code : U-1942

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-09-11

blank

06

arrow
BIO Partnering at JPM
Not Confirmed

BIOGEN IDEC

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

NUSINERSEN SODIUM

US Patent Number : 10266822

Drug Substance Claim :

Drug Product Claim :

Application Number : 209531

Patent Use Code : U-1942

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-12-05

blank

07

arrow
BIO Partnering at JPM
Not Confirmed

BIOGEN IDEC

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

NUSINERSEN SODIUM

US Patent Number : 8980853

Drug Substance Claim :

Drug Product Claim :

Application Number : 209531

Patent Use Code : U-1941

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-11-24

blank

08

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BIO Partnering at JPM
Not Confirmed

BIOGEN IDEC

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

NUSINERSEN SODIUM

US Patent Number : 9717750

Drug Substance Claim :

Drug Product Claim :

Application Number : 209531

Patent Use Code : U-1943

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-06-17

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09

arrow
BIO Partnering at JPM
Not Confirmed

BIOGEN IDEC

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

NUSINERSEN SODIUM

US Patent Number : 8110560

Drug Substance Claim :

Drug Product Claim :

Application Number : 209531

Patent Use Code : U-1942

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-12-05

blank

10

arrow
BIO Partnering at JPM
Not Confirmed

BIOGEN IDEC

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

NUSINERSEN SODIUM

US Patent Number : 10266822

Drug Substance Claim :

Drug Product Claim :

Application Number : 209531

Patent Use Code : U-1943

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-12-05

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ABOUT THIS PAGE

Nusinersen Sodium Manufacturers

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

Nusinersen Sodium Suppliers

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

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

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

Finished drug products

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

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

Nusinersen Sodium GMP

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

Nusinersen Sodium CoA

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

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

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