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01 6Dr. Reddy's Laboratories

02 1Octavius Pharma Pvt. Ltd

03 1AADI SUB

04 3Alkem Laboratories

05 1Amneal Pharmaceuticals

06 1Ananta Medicare

07 1Apotex Inc

08 3Ascent Innovative Medicines

09 3Glenmark Pharmaceuticals

10 1Hetero Drugs

11 30Johnson & Johnson

12 1Loxim Industries

13 1MSN Laboratories

14 4Murli Krishna Pharma

15 1Nobelpharma America

16 1Novitium Pharma LLC

17 1ORIFARM GROUP AS

18 4Panacea Biotec Limited

19 16Pfizer Consumer Healthcare

20 24Pfizer Inc

21 1Torrent Pharmaceuticals Limited

22 3Zydus 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

SIROLIMUS

Brand Name : SIROLIMUS

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Packaging :

Approval Date : 2014-10-27

Application Number : 201578

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOctavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

Regulatory Info :

Registration Country : India

Sirolimus

Brand Name : Sirolimus

Dosage Form : Granules for Tablets

Dosage Strength : 0.3; 0.6; 1.2%; %; %

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Octavius Pharma

03

  • 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

SIROLIMUS

Brand Name : SIROLIMUS

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date : 2014-10-27

Application Number : 201578

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Sirolimus

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Sirolimus

Brand Name :

Dosage Form : Oral Solid Dosage Form

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Filed

Registration Country : India

Dr Reddy Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Lead Market Dossiers- Approved in US

Registration Country : India

Sirolimus

Brand Name :

Dosage Form : Tablet

Dosage Strength : 1MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Approved in US

Registration Country : India

Dr Reddy Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

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

Regulatory Info : Lead Market Dossiers- Approved in US

Registration Country : India

Sirolimus

Brand Name :

Dosage Form : Tablet

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Lead Market Dossiers- Approved in US

Registration Country : India

Dr Reddy Company Banner

08

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : SIROLIMUS

Dosage Form : SOLUTION;ORAL

Dosage Strength : 1MG/ML

Packaging :

Approval Date : 2019-10-18

Application Number : 211212

Regulatory Info : RX

Registration Country : USA

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09

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : SIROLIMUS

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Packaging :

Approval Date : 2020-10-16

Application Number : 208691

Regulatory Info : RX

Registration Country : USA

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10

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : SIROLIMUS

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Packaging :

Approval Date : 2020-10-16

Application Number : 208691

Regulatory Info : RX

Registration Country : USA

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11

STLE Annual Meeting
Not Confirmed
arrow
arrow
STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : SIROLIMUS

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date : 2020-10-16

Application Number : 208691

Regulatory Info : RX

Registration Country : USA

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12

STLE Annual Meeting
Not Confirmed
arrow
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STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : SIROLIMUS

Dosage Form : SOLUTION;ORAL

Dosage Strength : 1MG/ML

Packaging :

Approval Date : 2019-01-28

Application Number : 211040

Regulatory Info : RX

Registration Country : USA

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13

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : RAPAMUNE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 1MG/ML

Packaging :

Approval Date : 1999-09-15

Application Number : 21083

Regulatory Info : RX

Registration Country : USA

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14

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : RAPAMUNE

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Packaging :

Approval Date : 2000-08-25

Application Number : 21110

Regulatory Info : RX

Registration Country : USA

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15

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : RAPAMUNE

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date : 2002-08-22

Application Number : 21110

Regulatory Info : RX

Registration Country : USA

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16

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : RAPAMUNE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Packaging :

Approval Date : 2004-02-23

Application Number : 21110

Regulatory Info : DISCN

Registration Country : USA

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17

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : RAPAMUNE

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Packaging :

Approval Date : 2010-01-25

Application Number : 21110

Regulatory Info : RX

Registration Country : USA

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18

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : SIROLIMUS

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Packaging :

Approval Date : 2023-02-15

Application Number : 201676

Regulatory Info : RX

Registration Country : USA

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19

STLE Annual Meeting
Not Confirmed
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STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : SIROLIMUS

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date : 2023-02-15

Application Number : 201676

Regulatory Info : RX

Registration Country : USA

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20

STLE Annual Meeting
Not Confirmed
arrow
arrow
STLE Annual Meeting
Not Confirmed

SIROLIMUS

Brand Name : SIROLIMUS

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Packaging :

Approval Date : 2014-01-08

Application Number : 201676

Regulatory Info : RX

Registration Country : USA

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