MOSL: CIPLA (Neutral)-Focused CAPA required to resolve regulatory issues
CIPLA: Focused CAPA required to resolve regulatory issues
(CIPLA IN, Mkt Cap USD5b, CMP INR442, TP INR465, 5% Upside, Neutral)
- The USFDA conducted an inspection at Cipla's (CIPLA) Goa formulation site from 19-27th Sep'19 and issued a form 483 with 12 observations.
- We note that these observations are related to (a) equipment cleaning, (b) inadequate control over air pressure/microorganism/dust, (c) deficiency in systems for equipment used to control aseptic conditions, (d) concerns about procedures designed to prevent microbiological contamination, (e) inadequate validation of the aseptic and sterilization process and (f) smoke study concerns related to air flow pattern, among others.
- According to CIPLA, the Goa plant contributes ~2.5% of total sales (10-12% of US sales) as a single source facility.
- While more focused corrective and preventive actions (CAPA) will be required to resolve these issues, the financial implication is likely to be minimal even if regulatory concerns at the site escalate, as (a) the company can in such a case shift large products to other sites and (b) not many (low-single-digit) ANDAs are pending for approval from this site over the near term.
Cipla is a global pharmaceutical company based in India. Co. manufactures over 1,000 pharmaceutical products for therapeutic areas such as cardiovascular, children's health, dermatology and cosmetology, diabetes, human immunodeficiency virus/acquired immuno deficiency syndrome (HIV/AIDS), infectious diseases and others. Co.'s operations are organized along four business units: Active Pharmaceutical Ingredients (API - 200 generic and complex APIs); Respiratory (inhalation therapy); Cipla Global Access (HIV/AIDS, malaria, multi drug-resistant tuberculosis, and reproductive health); and Veterinary. Co.'s products are sold in India, Africa, Middle East, Europe, Americas, Asia and Australia.
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