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01 6Dr. Reddy's Laboratories

02 1Octavius Pharma Pvt. Ltd

03 1AADI SUB

04 3Alkem Laboratories

05 1Amneal Pharmaceuticals

06 1Apotex Inc

07 3Ascent Innovative Medicines

08 3Glenmark Pharmaceuticals

09 1Hetero Drugs

10 30Johnson & Johnson

11 1MSN Laboratories

12 4Murli Krishna Pharma

13 1Nobelpharma America

14 1Novitium Pharma LLC

15 4Panacea Biotec Limited

16 16Pfizer Consumer Healthcare

17 33Pfizer Inc

18 2Plusultra Pharma Gmbh

19 1Rising Pharmaceuticals Inc

20 1Torrent Pharmaceuticals Limited

21 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 Pharma 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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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

IPPE
Not Confirmed
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IPPE
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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