Studied last few years AR’s using FDA as the keyword.
Inferences/Findings –
- The business lacks well-established GMP Processes although management claims otherwise.
Why so? Large Capex was planned in FY16 but repeated failure to pass USFDA inspection for F3-Karkhadi (General injectables ophthalmic) –
08-Feb-2021: 5 observations
10-Nov-2021: 10 observations
01-Sep-2022: 2 observations
The above seems excessive since management had the chutzpah and learning opportunities in the past.
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**Management's Chutzpah**(AR Commentary) : 2016- From a regulatory perspective: While our formulation facility was successfully audited by the USFDA, we have not grown complacent. We are making sizeable investments in IT infrastructure around data integrity, management and security. We are proactively strengthening our quality management capabilities to fulfill regulatory requirements. | 2017 – Compliant infrastructure: The Company cleared USFDA audits for its API, formulations and R&D units, thereby showcasing the institutionalisation of globally-best systems and processes. All our facilities – API units (at Panelav and Karkhadi) and oral solid dosage (OSD) facility (Panelav) – successfully cleared the USFDA audit, a vindication of our alignment with global best-practices and regulatory standards. -
**Management's learning opportunities**: 2018 – Formulation Facility (F1) at Panelav with three observations. 2020 – formulation oral solids facility in Panelav (F-1) was audited by the USFDA with four procedural observations. The F-I Facility has been subsequently classified as Voluntary Action Initiated.
- Investments (in F2, F3, and F4 facilities) to generate returns from ~24 months of receiving the relevant approvals from the regulatory bodies even though Capex for F2, F3, and F4 was completed in FY21.
- No word on USFDA inspection for F2-Panelav (Oncology injectables) and F4-Jarod (General oral solids)
Harsh (@harsh.beria93 ) – What keeps you optimistic to increase your bet size even though multiple risks (and may prolong) have materialized off-late?
Source – AR’s of various Years.
Disc – No Investment as of now.
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