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Piramal Pharma's Sellersville unit gets Form-483 with three observations from US FDA

11-May-26 09:23 Hrs IST

In a regulatory filing made on Sunday, the company stated that the US FDA had conducted a good manufacturing practices (GMP) inspection of Piramal Pharma's facility at Sellersville, USA, from 4th May 2026 to 8th May 2026.

At the conclusion of the inspection, US FDA issued a Form-483, with three observations.

At the closing meeting observations were recommended to be classified under VAI (voluntary action indicated) by inspectors. None of the observation relate to data integrity.

The company is preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines, Piramal Pharma said in a statement.

Piramal Pharma offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries.

The company a consolidated net loss of Rs 8.83 crore in the quarter ended March 2026 as against net profit of Rs 153.50 crore during the previous quarter ended March 2025. Sales declined 0.08% to Rs 2,751.77 crore in Q4 FY26 as compared with Q4 FY25.

The scrip shed 0.72% to currently trade at Rs 178.45 on the BSE.

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Sr No	Start Date	Department	Tender Details	Status
1	13-02-2026	Admin	RFP for Housekeeping and Security Guard	Closed
	10-03-2026		A. Financial BID Meeting Link
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2	31-01-2026	IT & IT Back Office	RFP - for Appointment of IAAP Certified Accessibility professionals as Auditors	Closed
			Schedule of Pre-Bid Meeting - RFP No. IFIN/IAAP/2025-26/002
	17-02-2026		Extension of – RFP No.: IFIN/IAAP/2025-26/002
	19-02-2026		Number of Pages - RFP No.: IFIN/IAAP/2025-26/002
	26-02-2026		Opening of Technical Bid - RFP No IFIN_IAAP_2025_26 002
	02-03-2026		Opening of Financial Bid - RFP No IFIN_IAAP_2025_26 002
	16-03-2026		Intimation of Award - RFP No. IFIN/IAAP/2025-26/002
3	28-01-2026	IT	RFP for Procurement of Sophos Firewall	Closed
			A. General Information
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			C. Financial BID
			D. Pre BID Meeting Link
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4	01-01-2026	IA	RFP for Appointment of Internal Auditors for Period April 2026 – March 2027	Open
5	01-01-2026	IA	RFP for Appointment of Concurrent Internal Auditors for Period April 2026 – March 2027	Open
6	27-11-2025	IT & IT Back office	RFP - for Appointment of IAAP Certified Accessibility professionals as Auditors	Cancelled
	27-01-2026	IT & IT Back office	RFP - for Appointment of IAAP Certified Accessibility professionals as Auditors	Cancelled
			A. Schedule of Pre-Bid Meeting - RFP No. IFIN/IAAP/2025-26/001
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7	30-10-2025		RFP for Vehicle Hiring
			A. General Information
			B. Technical BID Meeting Link
			C. Financial BID Meeting Link
8	02-09-2025	IT	RFP for Procurement of Server	Closed
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			B. Technical Bid
			C. Financial Bid
			D. Technical BID Meeting Link
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9	21-08-2025	IT	RFP for Procurement of Server	Closed
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			C. Financial Bid
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10	14-07-2025		RFP document for the Cloud Voice Logger	Closed
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11	01-04-2025	IA	REQUEST FOR PROPOSAL FOR APPOINTMENT OF CONCURRENT INTERNAL AUDITORS FOR PERIOD APRIL 2025 – MARCH 2026
12	01-04-2025	IA	REQUEST FOR PROPOSAL FOR APPOINTMENT OF INTERNAL AUDITORS FOR PERIOD APRIL 2025 – MARCH 2026 - IFCI
13	24-04-2025	IT	RFP for Services of IT Infrastructure Shifting & Configuration	Closed
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14	18-02-2025	IT	RFP for Procurement of HP Hard Disk	Closed
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15	18-02-2025	IT	RFP for Procurement of HP Server	Closed
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16	07-12-2024	Administration	RFP for office premises on lease at Chennai	Closed
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17	10-06-2024	IA	RFP for appointment of internal auditors for period April 2024 – March 2025	Active upto 21/06/2024 end of the day
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18	10-06-2024	IA	RFP for appointment of internal auditors and Concurrent Audit for period April 2024 – March 2025	Active upto 21/06/2024 end of the day
19	22-11-2023	Compliance	Procurement of AML/PML software Solution - VC Meeting Link for opening of Tender Box on 22/11/2023 at 4.30 pm	Closed
20	16-10-2023	Compliance	RFP for Procurement of AML/PML software solution
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21	28-10-2024	IT	RFP for Procurement of Firewall	Closed
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			B. Technical Bid
			C. Financial Bid
22	12-07-2023	ADMIN	RFP for Premises on Lease for Ahmedabad Branch
			A. Newspaper Aricle
			B. General Information
			C. Technical Bid
			D. Financial Bid
23	07-07-2023	CS	RFP for Secretarial Audit
24	26-06-2023	IT	RFP for AMC of Online UPS system installed at IFINs Branch office	Closed
			A. General Information
			B. Technical Bid
			C. Financial Bid
25	16-06-2023	IT	E-tender for engagement of annual system audit and cyber security audit agency	Closed
			A. General Information
			B. Technical Bid
			C. Financial Bid
26	15-06-2023	IT	RFP for AMC of 30KVA Online UPS system	Closed
			A. General Information
			B. Technical Bid
			C. Financial Bid
27	30-05-2023	ADMIN	RFP for Premises on Lease for Ahmedabad Branch	Cancelled
			A. Newspaper Aricle
			B. General Information
			C. Technical Bid
			D. Financial Bid
			E. Extension of RFP
			F. Closure of RFP
28	24-05-2023	ADMIN	RFP for Premises on Lease for Salem Branch	Closed
			A. Newspaper Aricle
			B. General Information
			C. Technical Bid
			D. Financial Bid
29	24-04-2023	IA	Extension Of RFP iCOM IA for FY 2023-2024	Closed
30	25-04-2023	CS	Extension Of RFP for Seeking Quotations for Secretarial Audit Of IFIN Group for FY 2022-2023	Cancelled
			A. Status_of_RFP_for_secretarila_audit
31	02-05-2023	IA	RFP For Appointment Of Internal Auditor for July 2023 - March 2024	Closed
32	02-05-2023	IA	RFP For Appointment Of Internal Auditor for July 2023 - March 2024 for operations, accounts and control related activities.	Closed
33	24-04-2023	CS	RFP PCS Empannelment for ROC filing 2022-23	Closed
34	24-04-2023	IA	RFP For Appointment Of Internal Auditor iCOM 23-24	Closed
35	14-03-2023	IA	RFP for appointment of internal auditor in the iCOM	Closed
36	25-04-2023	CS	RFP For Secretarial Audit 22-23	Closed

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