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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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NDC API

NDC API

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VMF

NDC API

API REF. PRICE (USD/KG)

$
$ 0

MARKET PLACE

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

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FDA Orange Book

FDA (Orange Book)

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Australia

Australia

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South Africa

South Africa

0 DRUGS IN DEVELOPMENT

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

PATENTS & EXCLUSIVITIES

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US Patents

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US Exclusivities

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Health Canada Patents

DIGITAL CONTENT

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Data Compilation #PharmaFlow

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Stock Recap #PipelineProspector

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Weekly News Recap #Phispers

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News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid

NA

Annual Reports

NA

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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API SUPPLIERS

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01

Beloorbayir Biotech

India

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

Biotech Showcase
Not Confirmed
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02

Anthem Biosciences

India

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

Biotech Showcase
Not Confirmed
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03

Newgen Biotech USA

U.S.A

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

Biotech Showcase
Not Confirmed
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Listed Suppliers

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01

Biotech Showcase
Not Confirmed
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Biotech Showcase
Not Confirmed

Alpha Amylase

About the Company : Anthem Biosciences is a leading contract research and innovation service provider (CRISP) in Bengaluru, India, which manufactures novel drug actives. Established in 2007, it specia...

Anthem Biosciences is a leading contract research and innovation service provider (CRISP) in Bengaluru, India, which manufactures novel drug actives. Established in 2007, it specializes in both biological and chemistry-based products and services. It has a strong track record in drug and product development, and supports development, optimization and testing of various compounds including proteins, monoclonal antibodies, peptides, large & small molecules and toxins. Inspected by USFDA, Japan’s PMDA, EU QPs, it develops nutritional products using organic synthesis and offers quality control and regulatory compliance assistance to clients.
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02

Biotech Showcase
Not Confirmed
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Biotech Showcase
Not Confirmed

Alpha Amylase

About the Company : The company is in the business of manufacturing and marketing botanical extracts and nutraceuticals formulations to both domestic and global customers. The products include health/...

The company is in the business of manufacturing and marketing botanical extracts and nutraceuticals formulations to both domestic and global customers. The products include health/dietary supplements for improving the overall wellness/prevention of diseases, ingredients for functional foods, food colors, and extracts. The company exports to around 35 countries in Europe, US, and Japan, with strong relations with global majors. The company has production facilities near Bengaluru (Peenya, Tumkur, Bidadi), Bhatkal, Hyderabad and Pune.
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03

Biotech Showcase
Not Confirmed
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Biotech Showcase
Not Confirmed

Amylase A

About the Company : Newgen Biotech® USA provides a global platform for accessing the highest quality ingredients and blends. We source our products from manufacturing sites that adhere to ISO9001, IS...

Newgen Biotech® USA provides a global platform for accessing the highest quality ingredients and blends. We source our products from manufacturing sites that adhere to ISO9001, ISO22000, HACCP, HARPC, and GMPs for NSF GMP for US Food, as well as pharmaceutical GMP standards for international companies with different standards from the US. As a well-established, contract manufacturer and distributor, we serve various industries such as Food & Beverage, Human Nutrition, and Cosmetics. Our key manufacturer's products and processes hold over 30 patents, and many of our offerings are certified HALAL, KOSHER, and comply with REACH standards.
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FDF Dossiers

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01

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
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AMYLASE

Brand Name : PANCREAKARE

Dosage Form : POWDER

Dosage Strength : 280000UNIT/2.8G

Packaging :

Approval Date :

Application Number : 2543664

Regulatory Info :

Registration Country : Canada

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02

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

AMYLASE

Brand Name : CREON MINIMICROSPHERES 25

Dosage Form : CAPSULE (DELAYED RELEASE)

Dosage Strength : 25500UNIT

Packaging : 100

Approval Date :

Application Number : 1985205

Regulatory Info :

Registration Country : Canada

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03

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

AMYLASE

Brand Name : CREON MINIMICROSPHERES MICRO

Dosage Form : GRANULES FOR SUSPENSION, DELAYED RELEASE

Dosage Strength : 5100UNIT/100MG

Packaging : 20G

Approval Date :

Application Number : 2445158

Regulatory Info :

Registration Country : Canada

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04

Viatris

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

U.S.A
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BIO Partnering at JPM
Not Confirmed

Amylasum; Lipasum; Proteasum

Brand Name : Creon 10000

Dosage Form : Capsules

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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05

Viatris

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

U.S.A
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BIO Partnering at JPM
Not Confirmed

Amylasum; Lipasum; Proteasum

Brand Name : Creon 10000

Dosage Form : Capsules

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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06

Viatris

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

U.S.A
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BIO Partnering at JPM
Not Confirmed

Amylasum; Lipasum; Proteasum

Brand Name : Creon 25000

Dosage Form : Capsules

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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07

Country
BIO Partnering at JPM
Not Confirmed
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Country
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BIO Partnering at JPM
Not Confirmed

AMYLASE

Brand Name : COTAZYM ECS 20

Dosage Form : CAPSULE (DELAYED RELEASE)

Dosage Strength : 100000UNIT

Packaging : 100/250

Approval Date :

Application Number : 821373

Regulatory Info :

Registration Country : Canada

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08

Country
BIO Partnering at JPM
Not Confirmed
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Country
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BIO Partnering at JPM
Not Confirmed

AMYLASE

Brand Name : PANCREASE MT 4

Dosage Form : CAPSULE (DELAYED RELEASE)

Dosage Strength : 17500UNIT

Packaging : 100

Approval Date :

Application Number : 789445

Regulatory Info :

Registration Country : Canada

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09

Country
BIO Partnering at JPM
Not Confirmed
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Country
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BIO Partnering at JPM
Not Confirmed

AMYLASE

Brand Name : COTAZYM

Dosage Form : CAPSULE (IMMEDIATE RELEASE)

Dosage Strength : 40000UNIT

Packaging : 100/1000

Approval Date :

Application Number : 263818

Regulatory Info :

Registration Country : Canada

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10

Country
BIO Partnering at JPM
Not Confirmed
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Country
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BIO Partnering at JPM
Not Confirmed

AMYLASE

Brand Name : VIOKACE

Dosage Form : TABLET

Dosage Strength : 56400UNIT

Packaging : 100

Approval Date :

Application Number : 2230019

Regulatory Info :

Registration Country : Canada

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Europe

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01

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Amylasum; Lipasum; Proteasum

Brand Name : Creon 10000

Dosage Form : Capsules

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Amylasum; Lipasum; Proteasum

Brand Name : Creon 10000

Dosage Form : Capsules

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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03

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Amylasum; Lipasum; Proteasum

Brand Name : Creon 25000

Dosage Form : Capsules

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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04

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Amylasum; Lipasum; Proteasum

Brand Name : Creon 25000

Dosage Form : Capsules

Dosage Strength :

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Canada

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01

Biotech Showcase
Not Confirmed
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Biotech Showcase
Not Confirmed

AMYLASE

Brand Name : PANCREAKARE

Dosage Form : POWDER

Dosage Strength : 280000UNIT/2.8G

Packaging :

Approval Date :

Application Number : 2543664

Regulatory Info :

Registration Country : Canada

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02

Biotech Showcase
Not Confirmed
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Biotech Showcase
Not Confirmed

AMYLASE

Brand Name : CREON MINIMICROSPHERES 25

Dosage Form : CAPSULE (DELAYED RELEASE)

Dosage Strength : 25500UNIT

Packaging : 100

Approval Date :

Application Number : 1985205

Regulatory Info :

Registration Country : Canada

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03

Biotech Showcase
Not Confirmed
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Biotech Showcase
Not Confirmed

AMYLASE

Brand Name : CREON MINIMICROSPHERES MICRO

Dosage Form : GRANULES FOR SUSPENSION, DELAYED RELEASE

Dosage Strength : 5100UNIT/100MG

Packaging : 20G

Approval Date :

Application Number : 2445158

Regulatory Info :

Registration Country : Canada

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04

Biotech Showcase
Not Confirmed
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Biotech Showcase
Not Confirmed

AMYLASE

Brand Name : CREON MINIMICROSPHERES 35

Dosage Form : CAPSULE (DELAYED RELEASE)

Dosage Strength : 35700UNIT

Packaging :

Approval Date :

Application Number : 2494639

Regulatory Info :

Registration Country : Canada

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05

ORGANON CANADA INC.

Country
Biotech Showcase
Not Confirmed
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ORGANON CANADA INC.

Country
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Biotech Showcase
Not Confirmed

AMYLASE

Brand Name : COTAZYM ECS 20

Dosage Form : CAPSULE (DELAYED RELEASE)

Dosage Strength : 100000UNIT

Packaging : 100/250

Approval Date :

Application Number : 821373

Regulatory Info :

Registration Country : Canada

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06

VIVUS LLC.

Country
Biotech Showcase
Not Confirmed
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VIVUS LLC.

Country
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Biotech Showcase
Not Confirmed

AMYLASE

Brand Name : PANCREASE MT 10

Dosage Form : CAPSULE (DELAYED RELEASE)

Dosage Strength : 43750UNIT

Packaging : 100

Approval Date :

Application Number : 789437

Regulatory Info :

Registration Country : Canada

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07

ORGANON CANADA INC.

Country
Biotech Showcase
Not Confirmed
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ORGANON CANADA INC.

Country
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Biotech Showcase
Not Confirmed

AMYLASE

Brand Name : COTAZYM ECS 8

Dosage Form : CAPSULE (DELAYED RELEASE)

Dosage Strength : 42000UNIT

Packaging : 100/500

Approval Date :

Application Number : 502790

Regulatory Info :

Registration Country : Canada

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08

ORGANON CANADA INC.

Country
Biotech Showcase
Not Confirmed
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ORGANON CANADA INC.

Country
arrow
Biotech Showcase
Not Confirmed

AMYLASE

Brand Name : COTAZYM

Dosage Form : CAPSULE (IMMEDIATE RELEASE)

Dosage Strength : 40000UNIT

Packaging : 100/1000

Approval Date :

Application Number : 263818

Regulatory Info :

Registration Country : Canada

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09

NESTLE ENTERPRISES S.A.

Country
Biotech Showcase
Not Confirmed
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NESTLE ENTERPRISES S.A.

Country
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Biotech Showcase
Not Confirmed

AMYLASE

Brand Name : VIOKACE

Dosage Form : TABLET

Dosage Strength : 56400UNIT

Packaging : 100

Approval Date :

Application Number : 2230019

Regulatory Info :

Registration Country : Canada

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10

NESTLE ENTERPRISES S.A.

Country
Biotech Showcase
Not Confirmed
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NESTLE ENTERPRISES S.A.

Country
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Biotech Showcase
Not Confirmed

AMYLASE

Brand Name : VIOKACE

Dosage Form : TABLET

Dosage Strength : 113400UNIT

Packaging : 100

Approval Date :

Application Number : 2241933

Regulatory Info :

Registration Country : Canada

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Listed Dossiers

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01

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
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Bacillus coagulans; Alpha Amylase; Pepsin; Immobilised Lipase

Brand Name : Tummysoft

Dosage Form : Dry Syrup

Dosage Strength : 500Million CFU; 25MG; ...

Packaging : 50ML

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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01

BIO Partnering at JPM
Not Confirmed
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BIO Partnering at JPM
Not Confirmed

Bacillus coagulans; Alpha Amylase; Pepsin; Immobilised Lipase

Dosage : Dry Syrup

Dosage Strength : 500Million CFU; 25MG; ...

Brand Name : Tummysoft

Approval Date :

Application Number :

Registration Country : India

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Global Sales Information

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Finished Drug Prices

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01

Brand Name : Creon 10000

U.S.A
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BIO Partnering at JPM
Not Confirmed

Brand Name : Creon 10000

U.S.A
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BIO Partnering at JPM
Not Confirmed

Alpha Amylase; Lipase

Dosage Form : Capsules

Dosage Strength :

Price Per Pack (Euro) : 14.85

Published in :

Country : Switzerland

RX/OTC/DISCN : Class D

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02

Brand Name : Creon 10000

U.S.A
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BIO Partnering at JPM
Not Confirmed

Brand Name : Creon 10000

U.S.A
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BIO Partnering at JPM
Not Confirmed

Alpha Amylase; Lipase

Dosage Form : Capsules

Dosage Strength :

Price Per Pack (Euro) : 26.13

Published in :

Country : Switzerland

RX/OTC/DISCN : Class D

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03

Brand Name : Creon 25000

U.S.A
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BIO Partnering at JPM
Not Confirmed

Brand Name : Creon 25000

U.S.A
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BIO Partnering at JPM
Not Confirmed

Alpha Amylase; Lipase

Dosage Form : Capsules

Dosage Strength :

Price Per Pack (Euro) : 30.4

Published in :

Country : Switzerland

RX/OTC/DISCN : Class D

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04

Brand Name : Creon 25000

U.S.A
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BIO Partnering at JPM
Not Confirmed

Brand Name : Creon 25000

U.S.A
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BIO Partnering at JPM
Not Confirmed

Alpha Amylase; Lipase

Dosage Form : Capsules

Dosage Strength :

Price Per Pack (Euro) : 60.56

Published in :

Country : Switzerland

RX/OTC/DISCN : Class D

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Market Place

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FDF DOSSIERS

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A Mauritian Ministry of Health & Quality of life is looking for formulation suppliers for the tender. Mentioned below formulations are required with following registrations: PIC country/ GCC country/ PBM/ Manufacturing site present either on the EUDRA/ USFDA database. 1. Alendronic Acid (as Sodium Alendronate) tab 35 mg (preferably strip/blister pack)- Qty: 155,000 2. Alfacalcidol tab/cap 0.25 mcg (preferably strip/blister pack)- Qty: 1,000,000 3. Alpha Amylase 3,000 units tabs (preferably strip/blister pack)- Qty: 950,000 4. Allopurinol tab 100 mg (preferably strip/blister pack)- Qty: 600,000 5. Colchicine tab 0.5/0.6 mg (preferably strip/blister pack)- Qty: 100,000 6. Diclofenac Inj. IM (25mg/ml x 3 ml)- Qty: 156,000 7. Pyridostigmine Bromide tab/cap 60 mg (preferably strip/blister pack)- Qty: 150,000 8. Allopurinol tab 300 mg (preferably strip pack)- Qty: 2,000,000 9. Calcium Carbonate 1.25 g (equivalent to elemental Calcium 500 mg) + Vit D3 400 iu (4 mg) chewable tab (preferably strip/blister pack)- Qty: 3,000,000 10. Diclofenac Sodium enteric coated tab 25 mg (preferably strip pack)- Qty: 700,000 11. Diclofenac Sodium enteric coated tab 50 mg (preferably strip pack)- Qty: 1,500,000 12. Diclofenac Sodium suppositories 50 mg (strip pack)- Qty: 925,000 13. Hydroxychloroquine Sulphate tabs 200 mg (preferably strip/blister pack)- Qty: 1,500,000 14. Ibuprofen tab 200 mg (preferably strip/blister pack)- Qty: 1,000,000 15. Ibuprofen tab 400 mg (preferably strip/blister pack)- Qty: 2,000,000 16. Indomethacin Suppositories 100 mg (strip pack)- Qty: 2,200,000 17. Methyl Salicylate Ointment (25% w/w x 15-30 g)- Qty: 1,400,000 18. Paracetamol tab 500 mg (preferably strip/blister pack)- Qty: 64,000,000 19. Paracetamol Suppositories 100-200 mg (strip pack)- Qty: 150,000 20. Paracetamol Suppositories 250-300 mg (strip pack)- Qty: 200,000 21. Paracetamol Suppositories 500-600 mg (strip pack)- Qty: 600,000 22. Quinine sulphate 200 mg tabs/caps (preferably strip/blister pack)- Qty: 14,000
22 Nov 2019

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22 Nov 2019

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22 Nov 2019

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