Aurobindo Pharma Limited announced on July 6th that its wholly owned subsidiary company, Eugia Pharma Specialities Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Triamcinolone Acetonide Injectable Suspension 200 mg/5 mL & 400 mg/10 mL. Triamcinolone Acetonide Injectable Suspension USP, 200 mg/5 mL (40 mg/mL), Multiple-dose vials and 400 mg/10 mL (40 mg/mL) Multiple-dose vials, to be bioequivalent and therapeutically equivalent to the RLD, Kenalog-40 Injectable Suspension, 40 mg/mL, of Bristol-Myers Squibb Company.
The product is being launched this month. The approved product has an estimated market size of around US$ 73 million for the twelve months ending May 2022, according to IQVIA. This is the 142nd ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
Triamcinolone Acetonide Injectable Suspension is in therapeutic Category of Synthetic glucocorticoid corticosteroid and indicated for the treatment of Intramuscular and Intra-Articular use:
- Intramuscular – Where oral therapy is not feasible: allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, neoplastic diseases (palliative treatment), nervous system, ophthalmic diseases, renal diseases, respiratory diseases, rheumatic disorders
- Intra-Articular – adjunctive therapy for short-term administration in: acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.
Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries.
The company has 24 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
This development is a relief for the company and will give stakeholders belief that the company can successfully deal with the challenges that have come it’s way from various regulatory agencies. On June 27th, 2022, the company informed the exchanges that it had received a warning letter from SEBI regarding non-compliance with SEBI regulations.
The announcement read as follows, “We have received a warning letter from Securities Exchange Board of India (SEBI) on June 24, 2022, a copy of which is enclosed. The letter is in regards to certain disclosures made by the Company on the ongoing USFDA audit of Company’s Unit-1 and observations made by the USFDA between the period 2019 to 2022.
“The SEBI warning letter observes that the Company had disclosed very limited and restricted information and that the Company did not disclose the detailed reasons and also did not consider-the observations of USFDA as serious. The Company is advised to ensure compliance with all applicable provisions of SEBI Regulations and to place this warning letter before its Board of Directors in ensuing Board Meeting. The Company is also instructed to disseminate this letter to the Stock Exchanges.”
The content of the SEBI letter are as follows-
- This has reference to the disclosure dated November 10, 2021 and January 14, 2022 made by Aurobindo Pharma Limited (“APUCompany”) under Regulation 30 of the SEBI LODR Regulations, 2015, to the Stock exchanges. The disclosure was related to the receipt of OAI (Official Action Indicated) & warning letter respectively from the United States Food and Drug Administration (USFDA) for Unit I. an API (Active Pharmaceutical Ingredients) manufacturing facility in Hyderabad, pursuant to an inspection carried out by the USFDA in August 2021 .
- APL vide corporate announcement dated November 10, 2021, informed about the communication received from USFDA classifying the inspection conducted by USFDA inspection team, at its Unit I between August 02 to August 12, 2021 as OAI. The company further stated that this classification will not affect the continuing commercial supplies to the US market from this facility. Subsequently, on January 14, 2022, APL disclosed that with regard to OAI classification of Unit I, Company had received a warning letter from the USFDA for the said unit.
- Fromm the disclosures made by the company, it was observed that the company had disclosed very limited and restricted information. The only fact disclosed was that a warning letter was received from USFDA. The company did not disclose the details on the reason and the noncompliance/aberration observed. for which the warning was issued.
- The company, in its response to SEBI, submitted that the company had communicated about the observations issued by the USFDA in the investor’s earning call on August 13, 2021 and that the transcript of the same was disclosed on the stock exchange platform.
- The above response was examined and it was found that the information disclosed by APL during investor call was same as the disclosure made and did not provide any additional information beyond what was already disclosed.
- The company further submitted to SEBI that the USFDA was not satisfied with the response of the company on two of the observations issued in the inspection by the USFDA, for which warning was issued in January 2022. These two observations issued were not considered serious by APL, as the company had already taken robust corrective actions to mitigate the risk. Further, the concerns raised by USFDA have already been adequately addressed and status of corrective actions being continuously updated to the USFDA.
- APL’s submission on not considering the warning as serious is not tenable. While the warning letter is available on the USFDA website, the company chose to make limited disclosure. Mere disclosure of the receipt of the USFDA warning letter is insufficient and an impediment to assess the current status.
- Having regard to the above, the disclosure by the company is not in line with the Principles Governing Disclosures and obligations of listed entity viz. Regulation 4 Ul of LODR Regulations read with Regulation 30 of SEBI (LODR) Regulations, 2015, wherein emphasis is laid on adequate and timely disclosure of material information to recognized stock exchanges.
- The aforesaid non-compliance is viewed seriously. You are hereby warned and advised to ensure compliance with all applicable provisions of SEBI Regulations. Any such aberration in future would be viewed seriously and appropriate action would be initiated.
- You are also advised to place this letter before your Board of Directors in its next meeting and disseminate the same to the stock exchange(s). The stock exchanges are advised to take note of the contents of the letter.”
SEBI website, company filings, analyst notes