Suppliers / Shivalik Rasayan

Shivalik Rasayan

India Updated 9 July 2026

Shivalik Rasayan is an API manufacturer based in India. It holds 2 active US drug master files and 6 valid CEPs across a filed portfolio of 8 molecules. Customs aggregates show $14K of exports covering 21 molecules to 6 destinations in 2025.

2
active US DMFs
6
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
New Delhi, India Not on file
Bharuch, India 3020983424

What they file, and where

Molecule Regulators Docs
Ambroxol EDQM 1
Bortezomib US FDA 1
Busulfan EDQM 1
Clonidine EDQM 1
Palbociclib US FDA 1
Pemetrexed Disodium EDQM 1
Pirfenidone EDQM 1
Temozolomide EDQM 1

Also appears on these molecule pages

Ambroxol API Bortezomib API Busulfan API Clonidine API Pemetrexed Disodium API Temozolomide API Pirfenidone API Palbociclib API

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $19K 3
2025 Not reported $14K 6
2024 Not reported $24K 3
2023 Not reported $56K 2

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Shivalik Rasayan

Does Shivalik Rasayan hold a US DMF or a CEP?
Shivalik Rasayan holds 2 active US drug master files and 6 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Shivalik Rasayan FDA-registered?
One site operated by Shivalik Rasayan carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
Where does Shivalik Rasayan manufacture?
2 registered sites are on record, in India (New Delhi and Bharuch). Every site is listed on this page with the register it came from.
What does Shivalik Rasayan make?
8 molecules are on record against Shivalik Rasayan, including Ambroxol, Bortezomib, Busulfan and Clonidine. Each links through to that molecule's full manufacturer list.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Comparable suppliers

Shilpa Pharma Lifesciences shares 4 molecules Hetero shares 3 molecules Reliance Life Sciences shares 3 molecules MSN Laboratories shares 2 molecules Dr Reddy's Laboratories shares 2 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
Customs aggregates
Export values, molecule and destination counts