Find Pegfilgrastim manufacturers, exporters & distributors on PharmaCompass

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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

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CEP/COS

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JDMF

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EU WC

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KDMF

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NDC API

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VMF

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REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

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PATENTS & EXCLUSIVITIES

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US Exclusivities

GLOBAL SALES INFORMATION

Regulatory FDF Prices

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MARKET PLACE

DIGITAL CONTENT

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Chemistry

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Also known as:
Molecular Formula
C27H46N4O19
Molecular Weight
730.7  g/mol
InChI Key
GAQMWPRWVIGRRV-IVDGIBIRSA-N

Pegfilgrastim
1 2D Structure

Pegfilgrastim

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R,4S,5R,6R)-2-[[(2R,3R,4R,5R,6S)-5-acetamido-6-[(1S,2R)-1-amino-1-carboxypropan-2-yl]oxy-3,4-dihydroxyoxan-2-yl]methoxy]-4-hydroxy-5-[[2-(2-methoxyethoxycarbonylamino)acetyl]amino]-6-[(1R,2R)-1,2,3-trihydroxypropyl]oxane-2-carboxylic acid
2.1.2 InChI
InChI=1S/C27H46N4O19/c1-10(16(28)23(40)41)48-24-18(30-11(2)33)21(39)20(38)14(49-24)9-47-27(25(42)43)6-12(34)17(22(50-27)19(37)13(35)8-32)31-15(36)7-29-26(44)46-5-4-45-3/h10,12-14,16-22,24,32,34-35,37-39H,4-9,28H2,1-3H3,(H,29,44)(H,30,33)(H,31,36)(H,40,41)(H,42,43)/t10-,12+,13-,14-,16+,17-,18-,19-,20+,21-,22-,24+,27-/m1/s1
2.1.3 InChI Key
GAQMWPRWVIGRRV-IVDGIBIRSA-N
2.1.4 Canonical SMILES
CC(C(C(=O)O)N)OC1C(C(C(C(O1)COC2(CC(C(C(O2)C(C(CO)O)O)NC(=O)CNC(=O)OCCOC)O)C(=O)O)O)O)NC(=O)C
2.1.5 Isomeric SMILES
C[C@H]([C@@H](C(=O)O)N)O[C@@H]1[C@@H]([C@H]([C@H]([C@H](O1)CO[C@@]2(C[C@@H]([C@H]([C@@H](O2)[C@@H]([C@@H](CO)O)O)NC(=O)CNC(=O)OCCOC)O)C(=O)O)O)O)NC(=O)C
2.2 Create Date
2013-02-04
3 Chemical and Physical Properties
Molecular Weight 730.7 g/mol
Molecular Formula C27H46N4O19
XLogP3-8.6
Hydrogen Bond Donor Count12
Hydrogen Bond Acceptor Count20
Rotatable Bond Count19
Exact Mass730.27562525 g/mol
Monoisotopic Mass730.27562525 g/mol
Topological Polar Surface Area365 Ų
Heavy Atom Count50
Formal Charge0
Complexity1170
Isotope Atom Count0
Defined Atom Stereocenter Count13
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

FDA Orange Book

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01

AMGEN

U.S.A
PEGS Boston Summit
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AMGEN

U.S.A
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PEGFILGRASTIM

Brand Name : NEULASTA

Dosage Form : SYRINGE

Dosage Strength : 6MG/0.6ML

Approval Date :

Application Number : 125031

RX/OTC/DISCN :

RLD :

TE Code :

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02

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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PEGFILGRASTIM-CBQV

Brand Name : UDENYCA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/0.6ML

Approval Date :

Application Number : 761039

RX/OTC/DISCN :

RLD :

TE Code :

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03

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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PEGFILGRASTIM-FPGK

Brand Name : STIMUFEND

Dosage Form : SOLUTION; INJECTION

Dosage Strength : 6MG/0.6ML

Approval Date :

Application Number : 761173

RX/OTC/DISCN :

RLD :

TE Code :

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04

HOSPIRA INC

U.S.A
PEGS Boston Summit
Not Confirmed
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HOSPIRA INC

U.S.A
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PEGS Boston Summit
Not Confirmed

PEGFILGRASTIM-APGF

Brand Name : NYVEPRIA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/0.6ML

Approval Date :

Application Number : 761111

RX/OTC/DISCN :

RLD :

TE Code :

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PEGS Boston Summit
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PEGS Boston Summit
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PEGFILGRASTIM-PBBK

Brand Name : FYLNETRA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/0.6ML

Approval Date :

Application Number : 761084

RX/OTC/DISCN :

RLD :

TE Code :

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06

SANDOZ INC

Switzerland
PEGS Boston Summit
Not Confirmed
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SANDOZ INC

Switzerland
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PEGS Boston Summit
Not Confirmed

PEGFILGRASTIM-BMEZ

Brand Name : ZIEXTENZO

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/0.6ML

Approval Date :

Application Number : 761045

RX/OTC/DISCN :

RLD :

TE Code :

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MYLAN GMBH

U.S.A
PEGS Boston Summit
Not Confirmed
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MYLAN GMBH

U.S.A
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PEGS Boston Summit
Not Confirmed

PEGFILGRASTIM-JMDB

Brand Name : FULPHILA

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 6MG/0.6ML

Approval Date :

Application Number : 761075

RX/OTC/DISCN :

RLD :

TE Code :

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Europe

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01

Accord Healthcare SLU

United Kingdom
PEGS Boston Summit
Not Confirmed
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Accord Healthcare SLU

United Kingdom
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PEGS Boston Summit
Not Confirmed

Pegfilgrastim

Brand Name : Pelgraz

Dosage Form : Solution For Injection

Dosage Strength : 6mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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02

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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Pegfilgrastim

Brand Name : Neulasta

Dosage Form : Injectable Solution

Dosage Strength : 6MG

Packaging :

Approval Date : 17-09-2009

Application Number : 2227004

Regulatory Info : Authorized

Registration Country : Spain

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03

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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Pegfilgrastim

Brand Name : Stimufend

Dosage Form : Solution For Injection

Dosage Strength : 6mg

Packaging :

Approval Date : 28-03-2022

Application Number : 28106438520

Regulatory Info : Prescription

Registration Country : Denmark

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04

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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Pegfilgrastim

Brand Name : Pelmeg

Dosage Form : Solution For Injection

Dosage Strength : 6mg/0.6ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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05

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
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Pegfilgrastim

Brand Name : Nyvepria

Dosage Form : Solution For Injection

Dosage Strength : 6mg

Packaging :

Approval Date : 19-11-2020

Application Number : 28106331019

Regulatory Info : Prescription

Registration Country : Denmark

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06

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed

Pegfilgrastim

Brand Name : Ziextenzo

Dosage Form : Solution For Injection

Dosage Strength : 6mg/0.6ml

Packaging :

Approval Date : 20/01/2020

Application Number : 67569

Regulatory Info : Allowed

Registration Country : Switzerland

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07

Sandoz GmbH

Switzerland
PEGS Boston Summit
Not Confirmed
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Sandoz GmbH

Switzerland
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PEGS Boston Summit
Not Confirmed

Pegfilgrastim

Brand Name : Ziextenzo

Dosage Form : Solution For Injection

Dosage Strength : 6mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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08

Teva BV

Israel
PEGS Boston Summit
Not Confirmed
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Teva BV

Israel
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PEGS Boston Summit
Not Confirmed

Lipegfilgrastim

Brand Name : Lonquex

Dosage Form : Solution For Injection

Dosage Strength : 6mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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09

Teva Bv

Israel
PEGS Boston Summit
Not Confirmed
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Teva Bv

Israel
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PEGS Boston Summit
Not Confirmed

Lipegfilgrastim

Brand Name : Lonquex

Dosage Form : Solution For Injection

Dosage Strength : 6mg

Packaging :

Approval Date : 25-07-2013

Application Number : 28105020511

Regulatory Info : Prescription

Registration Country : Denmark

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10

Teva Bv

Israel
PEGS Boston Summit
Not Confirmed
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Teva Bv

Israel
arrow
PEGS Boston Summit
Not Confirmed

Lipegfilgrastim

Brand Name : Lonquex

Dosage Form : Injectable Solution

Dosage Strength :

Packaging :

Approval Date : 04-10-2022

Application Number : 2.02E+13

Regulatory Info : Approved

Registration Country : Sweden

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ABOUT THIS PAGE

Looking for / Pegfilgrastim API manufacturers, exporters & distributors?

Pegfilgrastim manufacturers, exporters & distributors 1

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

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pegfilgrastim manufacturer or Pegfilgrastim supplier.

API | Excipient name

Pegfilgrastim

Pegfilgrastim Manufacturers

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

Pegfilgrastim Suppliers

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

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

Pegfilgrastim GMP

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

Pegfilgrastim CoA

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

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

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