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01 1Dr. Reddy's Laboratories

02 2Granules India Limited

03 1ANDAS 5 HOLDING

04 1Actavis Inc

05 1Aurobindo Pharma Limited

06 1Micro Labs Limited

07 1Takeda Pharmaceutical

08 1Upsher-Smith Laboratories

09 1Xiromed

10 1Zydus Pharmaceuticals

11 1i3 Pharmaceuticals

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : RX

Registration Country : USA

RAMELTEON

Brand Name : RAMELTEON

Dosage Form : TABLET;ORAL

Dosage Strength : 8MG

Packaging :

Approval Date : 2013-07-26

Application Number : 91693

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : RX

Registration Country : USA

RAMELTEON

Brand Name : RAMELTEON

Dosage Form : TABLET;ORAL

Dosage Strength : 8MG

Packaging :

Approval Date : 2020-08-21

Application Number : 213186

Regulatory Info : RX

Registration Country : USA

Granules India

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Regulatory Info : ROW, US

Registration Country : India

Ramelteon

Brand Name :

Dosage Form : Immediate Release Tablet

Dosage Strength : 8MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : ROW, US

Registration Country : India

Granules India

04

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

RAMELTEON

Brand Name : RAMELTEON

Dosage Form : TABLET;ORAL

Dosage Strength : 8MG

Packaging :

Approval Date : 2015-08-19

Application Number : 91610

Regulatory Info : RX

Registration Country : USA

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05

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

RAMELTEON

Brand Name : RAMELTEON

Dosage Form : TABLET;ORAL

Dosage Strength : 8MG

Packaging :

Approval Date : 2023-07-10

Application Number : 215972

Regulatory Info : RX

Registration Country : USA

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06

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

RAMELTEON

Brand Name : RAMELTEON

Dosage Form : TABLET;ORAL

Dosage Strength : 8MG

Packaging :

Approval Date : 2020-04-10

Application Number : 212650

Regulatory Info : RX

Registration Country : USA

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07

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

RAMELTEON

Brand Name : RAMELTEON

Dosage Form : TABLET;ORAL

Dosage Strength : 8MG

Packaging :

Approval Date : 2023-02-09

Application Number : 215243

Regulatory Info : RX

Registration Country : USA

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08

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

RAMELTEON

Brand Name : ROZEREM

Dosage Form : TABLET;ORAL

Dosage Strength : 8MG

Packaging :

Approval Date : 2005-07-22

Application Number : 21782

Regulatory Info : RX

Registration Country : USA

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09

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

RAMELTEON

Brand Name : RAMELTEON

Dosage Form : TABLET;ORAL

Dosage Strength : 8MG

Packaging :

Approval Date : 2020-10-26

Application Number : 213815

Regulatory Info : RX

Registration Country : USA

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10

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

RAMELTEON

Brand Name : RAMELTEON

Dosage Form : TABLET;ORAL

Dosage Strength : 8MG

Packaging :

Approval Date : 2022-11-25

Application Number : 216209

Regulatory Info : RX

Registration Country : USA

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11

American Pharma Summit
Not Confirmed
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American Pharma Summit
Not Confirmed

RAMELTEON

Brand Name : RAMELTEON

Dosage Form : TABLET;ORAL

Dosage Strength : 8MG

Packaging :

Approval Date : 2019-07-22

Application Number : 211567

Regulatory Info : RX

Registration Country : USA

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12

ANDAS 5 HOLDING

Country
American Pharma Summit
Not Confirmed
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ANDAS 5 HOLDING

Country
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American Pharma Summit
Not Confirmed

RAMELTEON

Brand Name : RAMELTEON

Dosage Form : TABLET;ORAL

Dosage Strength : 8MG

Packaging :

Approval Date : 2022-08-24

Application Number : 215435

Regulatory Info : RX

Registration Country : USA

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