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The FDA inspection was conducted at the company’s packaging facility in Manassas, Virginia, from December 1 to 3, 2025

The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder and has an estimated market size of around $41 million

Granules Pharmaceuticals Inc. has secured Tentative Approval for its ANDA for Amphetamine Extended-Release Orally Disintegrating Tablets

Granules Life Sciences has completed a GMP and Prior Approval Inspection by USFDA

This was the facility’s second FDA inspection, following the March 2023 audit that resulted in a No Action Indicated classification

The company has launched Ascelis Center of Excellence for Peptide Development and Characterization and the Granules Center of Excellence for Particle Engineering

Granules Pharmaceuticals, Inc. will hold 100% of the equity capital in Granules Pharmaceuticals Canada, Inc

The company plans to launch the approved product in the U.S. market soon

There was one observation during the inspection, and it has been resolved

The EIR was issued with an inspection classification of Voluntary Action Indicated post the inspection conducted in June 2025

The US-based arm of the company issued the Class III recall on August 28, 2025

The USFDA has conducted inspection from July 28, 2025 to August 01, 2025

The inspection was conducted from June 16, 2025 to June 20, 2025 and conluded with one 483 observation

The company has forayed into the CDMO space with the acquisition of Senn Chemicals AG

This acquisition enables Granules’ acquiring capabilities into high-growth peptide-based therapeutics

With this latest approval, the company now holds a total of 69 ANDA approvals, with 38 secured under the name of GIL and 31 under GPI

The company has received EU GMP certificate for APIs and FDs

The approved drug is available in multiple strengths: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg

Earlier, the USFDA had issued Form 483 with 6 observations for said facility

Granules’ goals are notable for their comprehensive scope and ambition

This recognition follows a highly competitive selection process with 499 applicants and a rigorous three-tier assessment

Granules now has a total of 67 ANDA approvals from the USFDA

The state-of-the-art mobile unit ‘Breast Health Express,’ brings advanced medical technology directly to communities in need

This facility manufactures APIs & formulations of oncology and non-oncology products

Earlier, the USFDA had issued Form 483 with 5 observations post inspection on December 16, 2023, which has been now classified as VAI

The company now has a total of 64 ANDA approvals from the USFDA

The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million

It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP

The certification has been received for accreditation categories of non-sterile Drugs, packaging, labelling and storage of drugs

The company has received the approval for compliance with the guidelines of Good Manufacturing Practices for its Bonthapally facility

The inspection was closed with zero observations

This product will be launched through Granules Consumer Health (GCH) division

This facility was inspected by the USFDA as a part of a PAI in January 2023 which resulted in 3 observations during the inspection

Unit IV facility located at Visakhapatnam manufactures Active Pharmaceutical Ingredients

Jeedimetla facility manufactures Active Pharmaceutical Ingredients and Pharmaceutical Formulation Intermediates

Granules now has a total of 58 ANDA approvals from USFDA

Granules now has a total of 57 ANDA approvals from USFDA

It is bioequivalent to the reference listed drug product, Effexor XR Extended-Release Capsules of Upjohn US 2 LLC

The facility recently received USFDA approval with zero 483 observations

The current annual U.S. market for Gabapentin Tablets is approximately $145 million

The facility was inspected by the US FDA from March 15, 2023 to March 20, 2023

Granules now has a total of 54 ANDA approvals from USFDA

This product will be manufactured at Granules manufacturing facility in Chantilly, Virginia and is expected to be launched shortly

The facility spread across 100 acres, will be commissioned in a phase wise manner

Granules now have a total of 52 ANDA approvals from US FDA

The company now have a total of 51 ANDA approvals from US FDA

Granules Pharmaceuticals, Inc. will respond to these observations within the stipulated time period