Find Pramlintide manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

0

CEP/COS

0

JDMF

0

EU WC

0

KDMF

0

VMF

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

FINISHED DOSAGE FORMULATIONS

0

Europe

0

Canada

0

Australia

0

South Africa

0

Listed Dossiers

FDF DossiersDRUG PRODUCT COMPOSITIONS

32RELATED EXCIPIENT COMPANIES

70EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

0

US Patents

0

US Exclusivities

0

Health Canada Patents

API/FDF Prices: Book a Demo

API REF. PRICE (USD/KG)

MARKET PLACE

0

FDF

DIGITAL CONTENT

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

0

News #PharmaBuzz

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
Also known as: Pramlintide acetate [usan], Schembl238214, Unii-726i6te06g, Aco137, 726i6te06g, 25-l-proline-28-l-proline-29-l-proline-, acetate (salt), hydrate
Molecular Formula
C171H269N51O53S2
Molecular Weight
3951  g/mol
InChI Key
NRKVKVQDUCJPIZ-MKAGXXMWSA-N

Pramlintide
Pramlintide Acetate is the acetate salt form of pramlintide, a peptide analogue of human amylin with 3 proline substitutions at position 25, 28 and 29, with antihyperglycemic activity. By mimicking amylin, pramlintide slows gastric emptying, inhibits digestive secretions (gastric acid, pancreatic enzymes, and bile), reduces glucagon secretion, and increases satiety; all of these actions are mediated mostly by glucose-sensitive areas in the brain stem. The overall result is a decrease in blood glucose levels. The use of pramlintide may cause an increased risk of insulin-induced hypoglycemia.
1 2D Structure

Pramlintide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-N-[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-4-amino-1-[[(2S)-4-amino-1-[[(2S)-1-[[2-[(2S)-2-[[(2S,3S)-1-[[(2S)-1-[(2S)-2-[(2S)-2-[[(2S,3R)-1-[[(2S)-4-amino-1-[[(2S)-1-[[2-[[(2S)-1-[[(2S)-4-amino-1-[[(2S,3R)-1-[[(2S)-1-amino-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-2-oxoethyl]amino]-3-methyl-1-oxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]carbamoyl]pyrrolidine-1-carbonyl]pyrrolidin-1-yl]-4-methyl-1-oxopentan-2-yl]amino]-3-methyl-1-oxopentan-2-yl]carbamoyl]pyrrolidin-1-yl]-2-oxoethyl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-3-(1H-imidazol-5-yl)-1-oxopropan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-1-oxopropan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-5-carbamimidamido-1-oxopentan-2-yl]-2-[[(2S,3R)-2-[[(2S)-2-[[(2R)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-4-amino-2-[[(2R)-2-[[(2S)-2,6-diaminohexanoyl]amino]-3-sulfanylpropanoyl]amino]-4-oxobutanoyl]amino]-3-hydroxybutanoyl]amino]propanoyl]amino]-3-hydroxybutanoyl]amino]-3-sulfanylpropanoyl]amino]propanoyl]amino]-3-hydroxybutanoyl]amino]pentanediamide
2.1.2 InChI
InChI=1S/C171H269N51O53S2/c1-21-81(12)130(163(268)207-110(56-78(6)7)169(274)222-53-33-42-118(222)170(275)221-52-32-41-117(221)160(265)219-135(89(20)230)167(272)206-109(66-125(180)238)151(256)212-128(79(8)9)161(266)186-68-126(239)192-111(70-223)154(259)203-107(64-123(178)236)152(257)218-134(88(19)229)166(271)195-98(136(181)241)57-92-43-45-94(231)46-44-92)214-159(264)116-40-31-51-220(116)127(240)69-187-141(246)101(58-90-34-24-22-25-35-90)199-148(253)105(62-121(176)234)201-149(254)106(63-122(177)235)202-155(260)112(71-224)209-156(261)113(72-225)208-146(251)103(60-93-67-184-75-188-93)205-162(267)129(80(10)11)213-150(255)100(55-77(4)5)198-145(250)102(59-91-36-26-23-27-37-91)200-147(252)104(61-120(175)233)196-137(242)82(13)189-144(249)99(54-76(2)3)197-142(247)96(39-30-50-185-171(182)183)193-143(248)97(47-48-119(174)232)194-165(270)132(86(17)227)215-138(243)83(14)190-157(262)114(73-276)211-168(273)133(87(18)228)216-139(244)84(15)191-164(269)131(85(16)226)217-153(258)108(65-124(179)237)204-158(263)115(74-277)210-140(245)95(173)38-28-29-49-172/h22-27,34-37,43-46,67,75-89,95-118,128-135,223-231,276-277H,21,28-33,38-42,47-66,68-74,172-173H2,1-20H3,(H2,174,232)(H2,175,233)(H2,176,234)(H2,177,235)(H2,178,236)(H2,179,237)(H2,180,238)(H2,181,241)(H,184,188)(H,186,266)(H,187,246)(H,189,249)(H,190,262)(H,191,269)(H,192,239)(H,193,248)(H,194,270)(H,195,271)(H,196,242)(H,197,247)(H,198,250)(H,199,253)(H,200,252)(H,201,254)(H,202,260)(H,203,259)(H,204,263)(H,205,267)(H,206,272)(H,207,268)(H,208,251)(H,209,261)(H,210,245)(H,211,273)(H,212,256)(H,213,255)(H,214,264)(H,215,243)(H,216,244)(H,217,258)(H,218,257)(H,219,265)(H4,182,183,185)/t81-,82-,83-,84-,85+,86+,87+,88+,89+,95-,96-,97-,98-,99-,100-,101-,102-,103-,104-,105-,106-,107-,108-,109-,110-,111-,112-,113-,114-,115-,116-,117-,118-,128-,129-,130-,131-,132-,133-,134-,135-/m0/s1
2.1.3 InChI Key
NRKVKVQDUCJPIZ-MKAGXXMWSA-N
2.1.4 Canonical SMILES
CCC(C)C(C(=O)NC(CC(C)C)C(=O)N1CCCC1C(=O)N2CCCC2C(=O)NC(C(C)O)C(=O)NC(CC(=O)N)C(=O)NC(C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(CC(=O)N)C(=O)NC(C(C)O)C(=O)NC(CC3=CC=C(C=C3)O)C(=O)N)NC(=O)C4CCCN4C(=O)CNC(=O)C(CC5=CC=CC=C5)NC(=O)C(CC(=O)N)NC(=O)C(CC(=O)N)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CC6=CN=CN6)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC7=CC=CC=C7)NC(=O)C(CC(=O)N)NC(=O)C(C)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(CCC(=O)N)NC(=O)C(C(C)O)NC(=O)C(C)NC(=O)C(CS)NC(=O)C(C(C)O)NC(=O)C(C)NC(=O)C(C(C)O)NC(=O)C(CC(=O)N)NC(=O)C(CS)NC(=O)C(CCCCN)N
2.1.5 Isomeric SMILES
CC[C@H](C)[C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N1CCC[C@H]1C(=O)N2CCC[C@H]2C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H](C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC3=CC=C(C=C3)O)C(=O)N)NC(=O)[C@@H]4CCCN4C(=O)CNC(=O)[C@H](CC5=CC=CC=C5)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H](CC6=CN=CN6)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC7=CC=CC=C7)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)N)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](C)NC(=O)[C@H](CS)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](C)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC(=O)N)NC(=O)[C@H](CS)NC(=O)[C@H](CCCCN)N
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Ac 0137

2. Ac 137

3. Lys-cys-asn-thr-ala-thr-cys-ala-thr-gln-arg-leu-ala-asn-phe-leu-val-his-ser-ser-asn-asn-phe-gly-pro-ile-leu-pro-pro-thr-asn-val-gly-ser-asn-thr-tyr-nh2

4. Pramlintide

5. Pramlintide Acetate

6. Tripro-amylin

2.2.2 Depositor-Supplied Synonyms

1. Pramlintide Acetate [usan]

2. Schembl238214

3. Unii-726i6te06g

4. Aco137

5. 726i6te06g

6. 25-l-proline-28-l-proline-29-l-proline-, Acetate (salt), Hydrate

7. 25-l-proline-28-l-proline-29-l-prolineamylin (human) Acetate (salt), Hydrate

2.3 Create Date
2007-07-03
3 Chemical and Physical Properties
Molecular Weight 3951 g/mol
Molecular Formula C171H269N51O53S2
XLogP3-16.7
Hydrogen Bond Donor Count58
Hydrogen Bond Acceptor Count59
Rotatable Bond Count122
Exact Mass3949.9396798 g/mol
Monoisotopic Mass3948.9363250 g/mol
Topological Polar Surface Area1690 Ų
Heavy Atom Count277
Formal Charge0
Complexity9620
Isotope Atom Count0
Defined Atom Stereocenter Count41
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 2  
Drug NameSymlin
PubMed HealthPramlintide (Injection)
Drug ClassesAntidiabetic
Active IngredientPramlintide acetate
Dosage FormInjectable
RouteSubcutaneous
Strengtheq 1.5mg base/1.5ml (eq 1mg base/ml); eq 2.7mg base/2.7ml (eq 1mg base/ml)
Market StatusPrescription
CompanyAstrazeneca Ab

2 of 2  
Drug NameSymlin
PubMed HealthPramlintide (Injection)
Drug ClassesAntidiabetic
Active IngredientPramlintide acetate
Dosage FormInjectable
RouteSubcutaneous
Strengtheq 1.5mg base/1.5ml (eq 1mg base/ml); eq 2.7mg base/2.7ml (eq 1mg base/ml)
Market StatusPrescription
CompanyAstrazeneca Ab

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Hypoglycemic Agents

Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)


USDMF

read-more
read-moreread-more

01

PharmaSynergy
Not Confirmed

01

PharmaSynergy
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12646

Submission : 1997-09-05

Status : Inactive

Type : II

blank

02

Polypeptide Sa

Switzerland

USDMF

arrow
PharmaSynergy
Not Confirmed

02

Polypeptide Sa

Switzerland
arrow
PharmaSynergy
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15096

Submission : 2000-10-16

Status : Inactive

Type : II

blank

03

PharmaSynergy
Not Confirmed

03

PharmaSynergy
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2018-04-30

Pay. Date : 2017-03-27

DMF Number : 31548

Submission : 2018-03-29

Status : Active

Type : II

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

NDC API

read-more
read-moreread-more

01

Bachem Americas, Inc.

Switzerland
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

Flag Switzerland
Digital Content Digital Content

PRAMLINTIDE ACETATE

NDC Package Code : 52416-106

Start Marketing Date : 2005-05-16

End Marketing Date : 2026-12-31

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

Marketing Category : BULK INGREDIENT

Bachem company banner

02

PharmaSynergy
Not Confirmed
arrow
arrow
PharmaSynergy
Not Confirmed

PRAMLINTIDE

NDC Package Code : 73212-099

Start Marketing Date : 2024-06-03

End Marketing Date : 2026-12-31

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

Marketing Category : BULK INGREDIENT

blank

03

PharmaSynergy
Not Confirmed
arrow
arrow
PharmaSynergy
Not Confirmed

PRAMLINTIDE ACETATE

NDC Package Code : 62756-689

Start Marketing Date : 2021-01-16

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (25kg/25kg)

Marketing Category : BULK INGREDIENT

blank

04

Qingdao Qinzeyuan Biotechnology Co....

Country
PharmaSynergy
Not Confirmed
arrow

Qingdao Qinzeyuan Biotechnology Co....

Country
arrow
PharmaSynergy
Not Confirmed

PRAMLINTIDE

NDC Package Code : 85512-1178

Start Marketing Date : 2025-06-02

End Marketing Date : 2027-12-31

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

Marketing Category : BULK INGREDIENT

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

read-more
read-more

01

PharmaSynergy
Not Confirmed
arrow
arrow
PharmaSynergy
Not Confirmed

Pramlintide

About the Company : We, Anhui Anke Biotechnology (Group) Co., Ltd., professional and comprehensive in developing, producing and marketing pharmaceuticals concerning genetic engineering products,diagn...

We, Anhui Anke Biotechnology (Group) Co., Ltd., professional and comprehensive in developing, producing and marketing pharmaceuticals concerning genetic engineering products,diagnostic products,precision medicine, polypeptide APIs, biochemistry and traditional Chinese medicines,staffed with abount qualified and creative R&D team and equipped with first-class facilities, certified by GMP and ISO9001. Our parent company is located in China Hefei New and High Technology Development Area. As based on high-efficient Research & Development Center, we, AnkeBio always keep up with international development and have been undertaken with 10 subjects such as "National 863 Projects", National scientific and technological project, National key Torch Program and Scientific and Technological Projects, key scientific and technological specialties of Anhui province and Natural Fund Project and etc. and have developed nearly 10 National Novel Drugs in recent years. Our dominant products, Recombinant Human Growth Hormone (Ansomone®), Series of Recombinant Human Interferon alpha 2b (Anterferon®), MAR Kit for Anti-sperm Antibody and etc., are all developed independently. These products have more and more significant therapeutically effect on clinical testing and application of many kinds of intractable disease such as chronic hepatitis B, tumor, leukemia, nutritional support burned wound and immunopurification sterility and etc. Our subsidiary companies like Anhui Anke Yuliangqing Pharmaceutical Co., Ltd., Anhui Anke Hengyi Pharmaceutical Co., Ltd. and Anhui Anke Yuliangqing Pharmaceutical Co., Ltd have been established from recombination of Anqing Yuliangqing Pharmaceutical Co., Ltd.,Tongling NO.1 Pharmaceutical Company dominated by Anke biotechnology Co.,Ltd. since year 2000.The products are extended from biomedical products into modern Chinese herb medicines and synthetic medicines.
blank

02

BCN Peptides

Spain
PharmaSynergy
Not Confirmed
arrow

BCN Peptides

Spain
arrow
PharmaSynergy
Not Confirmed

Pramlintide

About the Company : BCN Peptides is a privately own company completely focused on the cGMP manufacture of Bioactive Peptides for Pharmaceutical and Veterinary applications. We are a customer oriented...

BCN Peptides is a privately own company completely focused on the cGMP manufacture of Bioactive Peptides for Pharmaceutical and Veterinary applications. We are a customer oriented organization focused on fulfilling the client’s needs at each stage of the their peptide drug development and lifecycle management. It also includes a team of dedicated and passionate scientists which help us to provide to our customer a scientific excellence in terms of synthetic peptide chemistry and analytical expertise. BCN Peptides has an excellent track record of successful inspections by Global Health Agencies (US FDA, EDQM, KFDA,…)
blank

03

PharmaSynergy
Not Confirmed
arrow
arrow
PharmaSynergy
Not Confirmed

Pramlintide

About the Company : Shenzhen JYMed Technology Co.,Ltd is a high-tech enterprise engaged in research and development, manufacturing and commercialization of peptides based products, including active ph...

Shenzhen JYMed Technology Co.,Ltd is a high-tech enterprise engaged in research and development, manufacturing and commercialization of peptides based products, including active pharmaceutical ingredient peptides, cosmetic peptides, and custom peptides as well other new drug development. We strive for continuing innovations in new peptide synthesis technology and process optimization, and our technical team have over decade of experience in peptide synthesis. Our peptide plant is located in Nanjing, Jiangsu province and it has set up a facility of 30,000 square meters in compliance with cGMP guideline.
blank

04

PharmaSynergy
Not Confirmed
arrow
arrow
PharmaSynergy
Not Confirmed

Pramlintide

About the Company : Smaart Pharmaceutticals consciously strive for innovation through newer technologies, modern equipment available betterment of life and bring newer products for its customer. Smaa...

Smaart Pharmaceutticals consciously strive for innovation through newer technologies, modern equipment available betterment of life and bring newer products for its customer. Smaart has two state of the art manufacturing blocks. Our registered office is located at Jalgaon; which is our manufacturing facility as well. Geographically Jalgaon falls at North of Maharashtra, in the close vicinity of The famous ancient Buddhist cave temples of Ajanta; which were excavated between the 2d century BC and the 5th century AD.
blank

05

PharmaSynergy
Not Confirmed
arrow
arrow
PharmaSynergy
Not Confirmed

Pramlintide

About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and...

Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a year at 70 manufacturing facilities. We rank among the leading pharmaceutical companies in the world and are active in 60 countries. Approximately 43,000 employees around the world are dedicated to our mission. Building on our strong global footprint, size and scale, Teva is reaffirming its commitment to place people at the center of our strategy, and enable as many as possible to live better, healthier days.
blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

DRUG PRODUCT COMPOSITIONS

Do you need Business Intel? Ask us

DOSAGE - INJECTABLE;SUBCUTANEOUS - EQ 1.5MG B...DOSAGE - INJECTABLE;SUBCUTANEOUS - EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)

USFDA APPLICATION NUMBER - 21332

read-more

DOSAGE - INJECTABLE;SUBCUTANEOUS - EQ 2.7MG B...DOSAGE - INJECTABLE;SUBCUTANEOUS - EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)

USFDA APPLICATION NUMBER - 21332

read-more

Related Excipient Companies

Upload your portfolio for free, ask us

Excipients by Applications

Click here to find the perfect excipient manufacturers by their capabilities

Fillers, Diluents & Binders

read-more
read-more

Chewable & Orodispersible Aids

read-more
read-more

Taste Masking

read-more
read-more

Direct Compression

read-more
read-more

Disintegrants & Superdisintegrants

read-more
read-more

Parenteral

read-more
read-more

Co-Processed Excipients

read-more
read-more

Granulation

read-more
read-more

Solubilizers

read-more
read-more

Thickeners and Stabilizers

read-more
read-more

Digital Content read-more

Create Content with PharmaCompass, ask us

DATA COMPILATION #PharmaFlow

read-more
read-more

Global Sales Information

Do you need Business Intel? Ask us

Market Place

Do you need sourcing support? Ask us

REF. STANDARDS & IMPURITIES

Upload your portfolio for free, ask us

ABOUT THIS PAGE

Looking for / Pramlintide API manufacturers, exporters & distributors?

Pramlintide manufacturers, exporters & distributors 1

31

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

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

PharmaCompass also assists you with knowing the Pramlintide API Price utilized in the formulation of products. Pramlintide API Price is not always fixed or binding as the Pramlintide Price is obtained through a variety of data sources. The Pramlintide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Pramlintide

Synonyms

Pramlintide acetate [usan], Schembl238214, Unii-726i6te06g, Aco137, 726i6te06g, 25-l-proline-28-l-proline-29-l-proline-, acetate (salt), hydrate

About Pramlintide

Pramlintide Acetate is the acetate salt form of pramlintide, a peptide analogue of human amylin with 3 proline substitutions at position 25, 28 and 29, with antihyperglycemic activity. By mimicking amylin, pramlintide slows gastric emptying, inhibits digestive secretions (gastric acid, pancreatic enzymes, and bile), reduces glucagon secretion, and increases satiety; all of these actions are mediated mostly by glucose-sensitive areas in the brain stem. The overall result is a decrease in blood glucose levels. The use of pramlintide may cause an increased risk of insulin-induced hypoglycemia.

Pramlintide Manufacturers

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

Pramlintide Suppliers

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

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

Pramlintide USDMF

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

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

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

Pramlintide 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 Pramlintide as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Pramlintide GMP

Pramlintide 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 Pramlintide 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 Pramlintide GMP manufacturer or Pramlintide GMP API supplier for your needs.

Pramlintide CoA

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

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

Pramlintide may be tested according to a variety of international standards, such as European Pharmacopoeia (Pramlintide EP), Pramlintide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pramlintide 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty